Clinical Study Supply Partnerships for Rehab Research

Turn a Research Protocol into a Repeatable Supply Plan

A rehabilitation study may begin with a clinical question, but successful execution also depends on practical details: selecting a consistent device, obtaining enough electrodes, standardizing participant kits, documenting product identifiers, and preventing supply interruptions during enrollment.

Balego works with universities, academic medical centers, hospitals, rehabilitation programs, and independent research teams that need commercially available physical medicine and rehabilitation products for clinical studies, feasibility projects, and investigator-initiated research.

Depending on the study and available resources, support may include the following:

• Cohort-based product pricing
• Pilot quantities for feasibility testing
• Device and consumable selection assistance
• Standardized study-kit planning
• Institutional quotes and purchasing documentation
• Product identifiers and instructions for use
• Electrode-replenishment estimates
• Single-site or multisite shipment planning
• Direct-to-participant shipment evaluation
• Documentation of approved product donations or in-kind support
• Ongoing ordering support during enrollment

Have a protocol, concept sheet, or preliminary equipment list? Contact us about your research project and use the subject line Research Partnership Inquiry.

Who Balego Works With

Research inquiries may come from:

• Universities and academic medical centers
• Physical therapy and occupational therapy departments
• Rehabilitation hospitals and outpatient programs
• Kinesiology, biomechanics and human-performance laboratories
• Sports medicine and athletic-training researchers
• Neurology and neuromuscular programs
• Pain-management research groups
• Principal investigators conducting investigator-initiated studies
• Clinical research coordinators and study operations teams
• Nonprofit healthcare and rehabilitation organizations
• Sponsors or contract research organizations sourcing rehabilitation supplies

Balego can support both early planning and studies with an established protocol. The available pathway depends on enrollment, timeline, device requirements, shipping plan, and institutional purchasing rules.

Research Projects Balego May Be Able to Support

Product availability, pricing, direct shipment, and donated-equipment requests are reviewed individually. An inquiry does not guarantee funding, donated products, or a particular commercial arrangement.

What Balego Can—and Cannot—Provide

Clear role definitions help prevent confusion during institutional, IRB, and contracting review.

Unless another role is expressly established in a written agreement, Balego serves as a commercial product and supply partner, not as the study sponsor, contract research organization, medical monitor, or regulatory representative.

Research involving human participants remains subject to the institution’s ethical and regulatory review. FDA guidance assigns specific responsibilities to device-study sponsors and investigators, and IRBs can approve, require changes to, or disapprove covered human-subject research.

Rehabilitation Products Available for Study Planning

Balego offers several product categories frequently considered in rehabilitation, electrotherapy, sports medicine, and home-protocol research.

NMES Device Options for Research Cohorts

No single NMES device is ideal for every study. Researchers should begin with the intervention requirements rather than selecting by price alone.

NMES selection questions

Before requesting pricing, identify:

1. The muscle groups being stimulated
2. Number of simultaneous channels
3. Required pulse-rate and pulse-width ranges
4. Contraction, relaxation and ramp requirements
5. Whether participants may adjust settings
6. Whether treatment-use records are required
7. Required battery life or charging method
8. Electrode size and connector style
9. Planned sessions per week
10. Expected study duration
11. Whether the device will remain with the participant
12. Whether the device is being used within its labeling

For general device education, review our NMES units and muscle-stimulator collection. Protocol-specific settings must come from the research team.

TENS and Combination-Device Options

TENS research can range from simple sensory-stimulation studies to protocols comparing modes, electrode arrangements, or participant-controlled home use.

When choosing a TENS device, determine whether participants need fixed programs, investigator-defined parameters, or independent control of intensity. A device that is straightforward for one population may be unsuitable for participants with visual, cognitive, or dexterity limitations.

Electrode Planning for TENS, NMES, EMS, and FES Research

Electrodes are frequently underestimated during budgeting. Even when reusable for the same participant, they remain consumable items whose adhesion and electrical performance change over time.

Balego offers American-made TENS, NMES, and FES electrodes in several sizes, along with a broader electrotherapy electrode collection.

Variables that affect electrode quantities

Example electrode estimate

A study with 40 participants should not simply order 40 packages of pads without first defining the replacement assumption.

This figure is an inventory example, not a universal electrode-life recommendation. Actual quantities should be based on the selected electrode, session frequency, treatment area, and study procedures.

Building a Standardized Participant Kit

A written bill of materials helps ensure that every participant or study site receives the same approved components.

Example NMES or TENS kit

Pilot Quantity vs. Full-Cohort Purchasing

Purchasing the entire study supply before confirming feasibility may create unnecessary risk. Conversely, ordering only after each participant enrolls can cause delays.

For many studies, a practical approach is to order enough equipment for usability testing and initial enrollment, then establish predetermined replenishment points.

Single-Site vs. Multisite Supply Planning

A multisite inquiry should identify every planned site, approximate enrollment by location, and the person responsible for ordering and replacement approval.

Home-Based and Direct-to-Participant Studies

Home protocols introduce operational questions that do not arise when every session occurs under direct supervision.

Before selecting a home-use product, consider:

• Participant age and dexterity
• Visual or cognitive limitations
• Need for caregiver assistance
• Number of setup steps
• Ability to identify channels and lead wires
• Battery replacement or charging
• Electrode-placement repeatability
• How settings will be protected from unintended changes
• How technical questions will be routed
• What happens when equipment is lost or damaged
• Whether devices must be returned
• Privacy implications of participant-home shipping
• Site and institutional approval for direct shipment

Direct-to-participant shipment may be evaluated for suitable projects, but availability depends on product type, study structure, destination, privacy procedures, and institutional requirements.

Balego supplies commercial products and shipment documentation. The research organization is responsible for participant authorization, address handling, study-product accountability, and confirming that the protocol permits the shipping workflow.

Research Procurement and Documentation

Institutional purchasing teams may request more information than an ordinary online shopper.

Depending on the product and arrangement, Balego may be able to provide the following:

• Formal product quotations
• Product names and SKUs
• Manufacturer item numbers
• Unit and cohort pricing
• Shipping estimates
• Product-page specifications
• Instructions for use or user manuals when available
• Safety and contraindication information supplied by the manufacturer
• Warranty information
• Commercial invoices and packing slips
• Lot or expiration information when applicable and available
• Documentation describing approved donated or discounted products
• A factual description of Balego’s role in the project

Information to request early

Study-product guidance commonly recommends documenting receipt, product identity, lot numbers, expiration dates, dispensing, returns, and final disposition. Balego can supply ordinary commercial order records, while the investigator or designated study team maintains the study accountability log.

Donated Devices and In-Kind Research Support

Balego may review requests for donated products, pilot support, or research pricing. Availability depends on factors such as:

• Scientific and clinical relevance
• Institution and investigator
• Study design and stage
• Number and value of products requested
• Funding status
• Expected enrollment
• Project timeline
• Product availability
• Whether the request is for a pilot or full cohort
• Balego’s proposed role
• Documentation and contracting requirements

A complete inquiry is more likely to receive a useful response than a general request for “free devices.”

Include the following information with your donation request:

1. Study title and institution
2. Principal investigator and department
3. Brief abstract or protocol summary
4. Study status and anticipated IRB timeline
5. Target population
6. Number of participants
7. Exact product or technical requirements
8. Requested quantity
9. Estimated commercial value
10. Start date and study duration
11. Other funding sources
12. Requested acknowledgment, disclosure or publication language
13. Whether Balego would have any role beyond providing products

When a request is approved, the institution may ask for a factual letter identifying the product, quantity, estimated value, and limits of Balego’s involvement. Such documentation should accurately reflect the final written arrangement.

Research Independence, Disclosure and Publication

Receiving discounted or donated products does not, by itself, make Balego the study sponsor or grant it control over the research.

The written agreement should clarify:

• Who owns and controls the data
• Who conducts the analysis
• Whether Balego receives study updates
• Whether Balego may review a manuscript for confidential or factual product information
• Whether Balego has any publication rights
• How financial or in-kind support will be disclosed
• Whether Balego’s name or trademarks may be used
• Whether unused products must be returned
• Whether the study may describe the products as donated

Investigators should follow their institution’s conflict-of-interest policies, journal disclosure requirements, funding terms, and applicable regulations. For applicable clinical trials, registration and results-submission responsibility rest with the trial’s legally designated responsible party—generally the sponsor or an eligible designated principal investigator—not automatically with a commercial product supplier.

Information to Include in a Research Inquiry

Providing the following information allows Balego to evaluate product fit, quantity, and purchasing options more efficiently.

Study and institution

• Institution and department
• Principal investigator
• Research coordinator or operational contact
• Study title
• Brief abstract or protocol summary
• Funding source or current funding status
• IRB status
• Anticipated start date

Participants and sites

• Expected enrollment
• Number of study arms
• Number of sites
• Enrollment expected at each site
• Participant age group
• Important usability limitations
• Study duration per participant

Product requirements

• Modality: NMES, EMS, TENS, FES, IFC, or iontophoresis
• Required number of channels
• Required adjustable settings
• Treatment area and muscle groups
• Electrode size and shape
• Treatments per week
• Total treatment period
• Compliance-tracking requirement
• Battery or charging preference
• Prescription or labeling requirements
• Whether participants keep or return the device

Logistics and purchasing

• Total device quantity
• Consumable estimate
• Initial pilot quantity
• Desired reserve inventory
• Ship-to-site or home-shipment request
• Required delivery date
• Preferred purchasing method
• Request for bulk pricing, donation or another arrangement
• Documents required by procurement

Submit a research partnership inquiry to Balego.

How the Balego Research Supply Process Works

1. Submit the project summary

Send the available protocol, concept sheet, or operational requirements through the Balego contact form. Clearly identify the message as a research inquiry.

2. Define the technical requirements

Balego reviews the requested modality, device functions, electrode configuration, quantities, and expected treatment schedule.

3. Compare available commercial products

When more than one option could meet the stated requirements, Balego may provide product specifications and purchasing comparisons. The investigator makes the final protocol decision.

4. Establish quantities and the supply pathway

The team determines the pilot quantity, full-cohort estimate, reserve stock, shipment destinations, and consumable-replacement assumptions.

5. Complete procurement or support documentation

Balego supplies the approved quote, product information, and applicable commercial documents. Donation, discount, or other support arrangements must be confirmed in writing.

6. Receive and inspect the products

The study team verifies quantities, model numbers, package condition, and any applicable lot or expiration information.

7. Maintain study accountability

The investigator or delegated study staff records device assignment, disposable-product distribution, replacements, returns, and final disposition.

8. Reorder before reserve stock is exhausted

Enrollment and consumption should be reviewed throughout the study to prevent avoidable treatment interruptions.

Frequently Asked Questions

Does Balego donate devices to research studies?

Balego reviews requests for donated or partially supported products individually. Approval depends on the project, institution, quantities, available inventory, timeline, and requested scope of support.

Include a protocol summary, expected enrollment, exact quantity, and funding status with the request.

Does Balego offer research or cohort pricing?

Cohort-based pricing may be available for qualifying device, electrode, and consumable orders. Pricing depends on product, quantity, and shipment plan.

Can Balego help us choose a device?

Balego can compare available products against clearly stated technical and operational requirements, such as modality, channels, adjustable settings, power source, and electrode compatibility.

The principal investigator and clinical team remain responsible for choosing the intervention and determining its appropriateness for the protocol.

Can we order a small quantity before committing to the full study?

Yes, such an arrangement is possible when the products are available for ordinary commercial purchase. A pilot order can help evaluate participant handling, electrode placement, instructions, charging, and kit assembly before full-cohort purchasing.

Can Balego ship study equipment directly to participants?

Direct-to-participant shipment may be considered for appropriate projects. The study team must establish whether it is permitted by the protocol, consent, privacy procedures, and institutional requirements.

Can all participants receive identical devices?

Standardization is generally possible when sufficient inventory is reserved and the model remains available. Researchers should identify whether unapproved substitutions are prohibited and place orders early enough to reduce availability risk.

Can Balego provide products from one manufacturing lot?

Lot availability varies. Ask before ordering if a single lot is scientifically or operationally important. The research team should document the lots actually received and used.

Can Balego help estimate electrodes?

Yes. Provide the number of participants, channels, pads per setup, treatments per week, study duration, and expected replacement assumption.

Can electrodes be shared between participants?

Reusable self-adhering stimulation electrodes should be assigned to one participant and handled according to their labeling and study infection-control procedures.

Does Balego supply medication for iontophoresis studies?

The primary iontophoresis patches, electrodes, and controllers sold by Balego do not ordinarily include the study medication. Medication prescribing, preparation, storage, and dispensing must be handled through the study’s authorized clinical and pharmacy process.

Can Balego provide a donation or support letter for the IRB?

When an arrangement has been approved, Balego may be able to provide a factual letter that describes the products, quantity, estimated value, and agreed scope of involvement. The institution decides whether and how that letter is incorporated into its review.

Will Balego design the study protocol?

No. Balego can provide product specifications and operational supply information, but protocol design, clinical parameters, endpoints, safety monitoring, and statistical planning remain with the research team.

Does purchasing a cleared or commercially available device eliminate FDA or IRB requirements?

No. Commercial availability alone does not determine the regulatory status of a research use. Studies evaluating a new intended use, a modified product, or another investigational application may require additional review. The sponsor, investigator, IRB, and appropriate regulatory specialists should make that determination.

Who is responsible for ClinicalTrials.gov registration?

The legally designated responsible party—generally the sponsor or an eligible principal investigator designated by the sponsor—is responsible when registration or results submission is required. Balego does not become the responsible party merely by selling or donating products.

Contact Balego About a Clinical Study

To request product recommendations, cohort pricing, pilot quantities, or consideration of research support, send Balego:

• Institution and department
• Principal investigator
• Brief protocol or abstract
• Study population
• Expected enrollment and number of sites
• Target start date
• Required product functions
• Estimated device and consumable quantities
• Shipping plan
• Funding and procurement status
• Requested donation, discount or purchasing arrangement

Use the Balego contact form and enter:

Subject: Research Partnership Inquiry – Institution – Study Name

Balego will review the request and identify the product, procurement, and supply options that may be available.

Research and Regulatory Notice

Balego supplies commercially available rehabilitation, electrotherapy, and physical medicine products. Information provided by Balego is not medical, regulatory, statistical, or legal advice.

The study sponsor, principal investigator, and participating institutions are responsible for:

• Protocol development
• Risk determination
• IRB or ethics review
• FDA and other regulatory submissions when applicable
• Informed consent
• Participant training and monitoring
• Device accountability
• Safety and adverse-event reporting
• Data integrity
• Trial registration and results reporting
• Conflict-of-interest disclosure
• Analysis and publication

Product availability, technical assistance, discounted pricing, direct shipment, and in-kind support are evaluated case by case and must be documented before being represented in a protocol, budget, consent form, publication, or institutional submission.