Telerehabilitation for Post-Stroke Hand Function
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorUniversity of Michigan
About this trial
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a home-based, technology-enabled hand telerehabilitation program for adults with chronic stroke. Participants will receive either remotely guided hand training or a standard home exercise program matched for duration and intensity. Outcomes will include measures of hand function, adherence, and feasibility to assess the potential of telerehabilitation for improving access to structured post-stroke hand rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral cortical or subcortical stroke
Chronic stroke (≥ 6 months since stroke)
No significant cognitive deficits as determined by the Mini Mental State Examination (MMSE) score (score≥ 22)
Disqualifiers
Cerebellar stroke
Unstable heart condition, uncontrolled diabetes or hypertension
Recent trauma or fracture in the upper extremities
History of significant orthopedic or neurological conditions that could affect hand function (e.g., multiple sclerosis)
Trial design
Design model
Parallel
Treatments tested in this trial
Technology-Supported Hand Training
BehavioralParticipants will undergo a remotely delivered, technology-supported hand training program that involves guided hand activities. These activities will target finger coordination, finger individuation, and performance in activities of daily living. Participants may interact with virtual or real passive items to supplement program activities. Activities will be guided remotely by a study team member using video conferencing.
Pamphlet-Supported Hand Activity
BehavioralParticipants will follow a home advice plan to improve hand function. The plan will be created based on the participant's ability and typical occupational therapy guidance. Activities may resemble typical hand rehabilitation activities performed in a therapy clinic and may involve passive items to supplement program activities. Participants will record their adherence to the program.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Technology-Supported Hand Training GroupExperimental treatment 1 intervention
Group B: Pamphlet-Supported Hand Activity GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hand Spread
Change in voluntary ability to open the more-impaired hand from before the intervention (pre-intervention) to after the intervention (post-intervention). Hand spread will be measured with motion capture equipment. Hand Spread values range from 0 to no upper limit, with a greater value indicating improved voluntary hand opening ability
Time frame
Pre-intervention (an average of up to 1 week before the first intervention session) and post-intervention (an average of up to 1 week after completion of the 6-week intervention)2
Box and Block Test Score
Change in a measure of arm ability from before the intervention (pre-intervention) to after its completion (post-intervention) using publicly available scoring sheets. The Box and Block test is scored based on how many blocks a patient can move between two adjacent boxes in 1 minute with their more-impaired hand. Box and Block scores range from 0 to no upper limit, with a higher score indicating greater arm ability
Time frame
Pre-intervention (an average of up to 1 week before the first intervention session) and post-intervention (an average of up to 1 week after completion of the 6-week intervention)3
Stroke Impact Scale-Hand Score
Change in the hand function component of the Stroke Impact Scale, a participant-reported measure of hand participation in daily life from before the intervention (pre-intervention) to after its completion using publicly available scoring sheets. Stroke Impact Scale-Hand Scores can range from 0 to 100, with a higher score indicating better self-reported hand function in daily life.
Time frame
Pre-intervention (an average of up to 1 week before the first intervention session) and post-intervention (an average of up to 1 week after completion of the 6-week intervention)Other outcomes
1
Adherence
Measure of percentage of sessions completed
Time frame
Post-intervention (immediately following last session of intervention)2
Qualitative Survey
Subjective feedback regarding feasibility, acceptance, and perceived functional benefits of the intervention. The qualitative survey has no scale.
Time frame
Post-intervention (an average of up to 1 week after completion of the 6-week intervention)3
Upper extremity Fugl-Meyer Score (Hand Section) Score
Change in the score on the Hand subsection of the Fugl-Meyer Assessment of Motor Recovery After Stroke - Upper Extremity from pre-intervention to post-intervention. The Hand subsection measures motor impairment of the hand and ranges from 0 to 14 points, with higher scores indicating better motor function.
Time frame
Pre-intervention (an average of up to 1 week before the first intervention session) and post-intervention (an average of up to 1 week after completion of the 6-week intervention)4
Principal Component Ratio
Change in coordination of the finger joints as measured with motion capture from before the intervention (pre-intervention) to after its completion (post-intervention). The ratio of the variance explained by the non-primary coordination patterns to the primary pattern during a free exploration task will be used to compute the Principal Component Ratio. The principal component ratio can vary from 0 to no upper limit, with a higher ratio indicates improved coordination.
Time frame
Pre-intervention (an average of up to 1 week before the first intervention session) and post-intervention (an average of up to 1 week after completion of the 6-week intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov