Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury

NCT06907381 | Enrolling By Invitation

• 1 other identifier: QualityLiving BFRE
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Blood flow-restricted resistance exercise; Physical therapy; Rehabilitation; Electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Change in muscle strength

  Change in strength of target muscle(s) contraction as measured in pounds of force using a dynamometer.

  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

  Baseline and end of treatment at a maximum of 6 months

• Change in support required to perform functional task

  Baseline and end of treatment at a maximum of 6 months

• Change in perceived exertion when performing a functional task

  Baseline and end of treatment at a maximum of 6 months

Interventions

Blood flow-restricted resistance exercise BEHAVIORAL

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.

Also known as: BFRE

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quality Living, Inc.: lead

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

Study Officials

• Sara Waid, DPT

  Quality Living, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)