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

• Conditions: Spinal Cord Injury Cervical

• Registration Number: NCT06907381
• Lead Sponsor: Quality Living, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in muscle strength	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.

Secondary Outcome Measures

Name	Time	Method
Change in number of repetitions of unassisted target muscle(s) contractions	Baseline and end of treatment at a maximum of 6 months	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.
Change in support required to perform functional task	Baseline and end of treatment at a maximum of 6 months	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.
Change in perceived exertion when performing a functional task	Baseline and end of treatment at a maximum of 6 months	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.

Trial Locations

Locations (1)

Quality Living, Inc.; 🇺🇸 Omaha, Nebraska, United States