Clinical trial NCT04977037: A Telerehabilitation Program for SCI
Official title: Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: Cervical Spinal Cord Injury
upper limb
tDCS
telerehabilitation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Mission Connect a project of TIRR Foundation
First posted: 2021-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).

Detailed description: Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months post-injury;
2. upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble;
3. no brain injury;
4. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
5. no contradiction to tDCS;
6. access to internet at home.

Exclusion Criteria:

1. prior history of seizure;
2. chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants);
3. any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.

Primary outcomes:
measure: Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: Baseline
measure: Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: 2 weeks
measure: Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: 6 weeks
Secondary outcomes:
measure: Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended
timeFrame: Treatment Day 1- Day 10
measure: Adherence With the Therapy as Assessed by the Number of Participant Drop-outs
timeFrame: Between enrollment and 6 weeks
measure: Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS)
timeFrame: Day 10
measure: Grip Strength
timeFrame: Baseline
measure: Grip Strength
timeFrame: 2 weeks
measure: Grip Strength
timeFrame: 6 weeks
measure: Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
timeFrame: Baseline
measure: Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
timeFrame: 2 weeks
measure: Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
timeFrame: 6 weeks
measure: Number of Participants Who Had Adverse Events
timeFrame: from baseline to 6 weeks
measure: Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS)
timeFrame: Day 10
measure: Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using Exercise Equipment as Assessed by the Visual Analog Scale (VAS)
timeFrame: Day 10
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Sciences Center at Houston
name: Nuray Yozbatiran, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: