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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal Cord Injury Cervical
• Intervention / Treatment: Behavioral: Blood flow-restricted resistance exercise

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68104
      • Quality Living, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and end of treatment at a maximum of 6 months

Collaborators and Investigators

• Sponsor: Quality Living, Inc.
• Investigators: Principal Investigator: Sara Waid, DPT, Quality Living, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; Electrical stimulation; Blood flow-restricted resistance exercise
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: QualityLiving BFRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No