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Completed

NCT Number: NCT06907381

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

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.

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Key information

Conditions

Spinal Cord Injury Cervical

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BFRE

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in number of repetitions of unassisted target muscle(s) contractions

    Time frame: 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.

  2. Change in support required to perform functional task

    Time frame: 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.

  3. Change in perceived exertion when performing a functional task

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Quality Living, Inc.

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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