Spinal Cord Injury CervicalNCT06907381
Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury
An observational study of Spinal Cord Injury Cervical, run by Quality Living, Inc. at 1 site in United States.
Trial summary
Recovery of arm and hand motor control is critical for independence and quality of life following incomplete spinal cord injury (iSCI). Blood flow-restricted resistance exercise (BFRE) has emerged as a potential treatment addressing this need, but treatment guidelines and research reporting effectiveness are sparse. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Blood flow-restricted resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 24 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will include adults with incomplete cervical spinal cord injury. They will be medically stable and enrolled in Quality Living's rehabilitation program in Omaha, NE, at the time of participation. Level of injury can vary from C3 to C8. Participants will demonstrate sensory and motor function consistent with AIS B, C, or D classification.
Who may be able to join
- Incomplete cervical spinal cord injury
- Resting blood pressure between 80/50 mmHg and 150/90 mmHg for at least three consecutive days
- Native speaker of English
Who cannot join
- Recent history of deep vein thrombosis or cardiovascular disease including uncontrolled hypertension or a blood-clotting disorder
- Routine experience of orthostatic hypotension as defined as a drop in systolic/diastolic blood pressure greater than 20/10 mmHg when engaging in physical activity
- Severe cognitive, communication, or behavioral disorder as determined by treatment team
Trial locations and contacts
1 site in 1 country.
About this study
Recovery of arm and hand motor control is critical for independence and quality of life following incomplete spinal cord injury (iSCI). Blood flow-restricted resistance exercise (BFRE) has emerged as a potential treatment addressing this need, but treatment guidelines and research reporting effectiveness are sparse. The purpose of this work is to provide case reports of people with cervical iSCI who use BFRE supplemented by electrical stimulation (ES) to increase the strength and functional use of selected upper extremity muscles.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Blood flow-restricted resistance exercise
- Keywords
- Blood flow-restricted resistance exercise, Physical therapy, Rehabilitation, Electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow-restricted resistance exerciseBehavioural
Also called BFRE
Participants will engage in baseline measurement of blood pressure, strength of target muscle contractions, and level of support needed for functional task performance. They will then begin BFRE treatment supplemented by electrical stimulation, if needed, two times weekly. Each exercise session will include performance of four sets of 20 repetitions of target muscle contraction on each side of the body followed by functional task performance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Change in strength of target muscle(s) contraction as measured in pounds of force using a dynamometer.
Measured: Baseline and end of treatment at a maximum of 6 months
Secondary outcomes (3)
Change in number of repetitions of unassisted target muscle(s) contractions
Tally of the number of target muscle contractions participant can perform during a single treatment session (80 repetitions max) without BFRE or electrical stimulation assistance.
Measured: Baseline and end of treatment at a maximum of 6 months
Change in support required to perform functional task
Professional assessment using the 7-point Functional Independence Measure (1 = total assistance; 7 = complete independence) to rate the level of support a participant requires to perform a functional task.
Measured: Baseline and end of treatment at a maximum of 6 months
Change in perceived exertion when performing a functional task
Participants will use the Borg category-ratio 10 Rating Exertion scale (0 = no exertion; 10 = highest level of effort) to rate the effort they expend to perform a functional task.
Measured: Baseline and end of treatment at a maximum of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Waid, DPT, Principal investigator, Quality Living, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907381
- Sponsor's protocol ID
- QualityLiving BFRE
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will only consider sharing data in de-identified form and used in publications or presentations resulting from this research. Given that data will be from case examples, we need to exercise extreme caution to ensure the protection of participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06907381
- Acronym / sponsor ID
- QualityLiving BFRE
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Blood flow-restricted resistance exercise, Physical therapy, Rehabilitation, Electrical stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recovery of arm and hand motor control is critical for independence and quality of life following incomplete spinal cord injury (iSCI). Blood flow-restricted resistance exercise (BFRE) has emerged as a potential treatment addressing this need, but treatment guidelines and research reporting effectiveness are sparse. The purpose of this work is to provide case reports of people with cervical iSCI who use BFRE supplemented by electrical stimulation (ES) to increase the strength and functional use of selected upper extremity muscles.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include adults with incomplete cervical spinal cord injury. They will be medically stable and enrolled in Quality Living's rehabilitation program in Omaha, NE, at the time of participation. Level of injury can vary from C3 to C8. Participants will demonstrate sensory and motor function consistent with AIS B, C, or D classification.
Key inclusion criteria (3 listed)
- Incomplete cervical spinal cord injury
- Resting blood pressure between 80/50 mmHg and 150/90 mmHg for at least three consecutive days
- Native speaker of English
Key exclusion criteria (3 listed)
- Recent history of deep vein thrombosis or cardiovascular disease including uncontrolled hypertension or a blood-clotting disorder
- Routine experience of orthostatic hypotension as defined as a drop in systolic/diastolic blood pressure greater than 20/10 mmHg when engaging in physical activity
- Severe cognitive, communication, or behavioral disorder as determined by treatment team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow-restricted resistance exerciseAlso: BFREParticipants will engage in baseline measurement of blood pressure, strength of target muscle contractions, and level of support needed for functional task performance. They will then begin BFRE treatment supplemented by electrical stimulation, if needed, two times weekly. Each exercise session will include performance of four sets of 20 repetitions of target muscle contraction on each side of the body followed by functional task performance. | Behavioural | – |
Primary outcome
Change in muscle strength
Time frame: Baseline and end of treatment at a maximum of 6 months
Change in strength of target muscle(s) contraction as measured in pounds of force using a dynamometer.
3 secondary outcomes
Change in number of repetitions of unassisted target muscle(s) contractions
Time frame: Baseline and end of treatment at a maximum of 6 months
Change in support required to perform functional task
Time frame: Baseline and end of treatment at a maximum of 6 months
Change in perceived exertion when performing a functional task
Time frame: Baseline and end of treatment at a maximum of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided. We will only consider sharing data in de-identified form and used in publications or presentations resulting from this research. Given that data will be from case examples, we need to exercise extreme caution to ensure the protection of participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Waid, DPT principal investigator
Quality Living, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury Cervical, run by Quality Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength (time frame: Baseline and end of treatment at a maximum of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.