Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVirginia Commonwealth University

About this trial

The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.

Participants must have a companion that will be able to help him/her throughout the study.

Greater than 1-year post SCI, neurologic level of C8 or above.

American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.

Disqualifiers

Unhealed fracture in upper or lower extremities.

Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.

High resting blood pressure greater than 140/80 mmHg.

Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BES + TS

    Procedure/Surgery

    Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

  • Experimental: BES+sham TS

    Procedure/Surgery

    Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: BES+TSExperimental treatment 1 intervention
Group B: BES+sham TSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in hand functional activities

The grasp and release test is a standardized test of functional activities depending on hand function in persons with cSCI. Participants will be asked to lift and move a peg, block, can, 1 lb. dumbbell weight and fork from lateral to medial over a 60 cm distance and release at midline.

Time frame
Baseline to 20 weeks
2

Change in maximum grip strength without TS

Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand

Time frame
Baseline to 20 weeks
3

Change in maximum grip strength with TS

Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand with the addition of TS over the skin targeting the cervical spinal cord

Time frame
Baseline to 20 weeks
4

Change in electrical activity activation with TS

During the assessment of maximal grip strength with TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation from the following muscle groups: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.

Time frame
Baseline to 20 weeks

Secondary outcomes

1

Changes in capacity to perform functional activities

Functional activity will be measured using the Spinal Cord Injury-Functional Index Short Form (SCI-FI SF). The SCI-FI SF is a comprehensive measure of functional activity capacity for persons with SCI. It measures three subscales: Basic Mobility (9 items), Self-Care (9 items), and Fine Motor Function (8 items). Participants respond to item prompts using a Likert-type scale with anchors from 1 = "With much difficulty" to 4 = "Without any difficulty." Item scores for each subscale are summed and then converted to standardized T-scores, with higher scores reflecting greater functional capacity. We will use the tetraplegia-specific versions of the Self-Care and Fine Motor Function subscales.

Time frame
Baseline to 20 weeks
2

Change in vital capacity

Forced vital capacity is an evaluation of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor. Participants will be asked to seal their lips around a disposable mouthpiece connected to the respiratory monitor via an anti-viral/anti-bacterial filter, then take a maximal inhalation immediately followed by a forceful exhalation which participants will be encouraged to maintain for as long as possible.

Time frame
Baseline to 20 weeks
3

Change in ventilatory muscle strength

Maximal inspiratory pressure and maximal expiratory pressure using a digital respiratory pressure meter are measures of ventilatory muscle strength. Participants will be asked to exhale fully, then seal their lips around a disposable mouthpiece and inhale as strongly as possible against an occlusion. They will be asked to inhale maximally and then exhale through a disposable mouthpiece against an occlusion.

Time frame
Baseline to 20 weeks
4

Change in heart rate variability

Tilt table test for heart rate variability will be used to assess changes in heart rate variability.

Time frame
Baseline to 20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

ACL Administration for Community Living

Collaborator