Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011
Ann Arbor, Michigan, 48108, United States
Location status: Recruiting
Location contact
Chandramouli Krishnan, PT, PhD
CONTACT
Thomas E Augenstein, MSE, PhD
CONTACT
NCT Number: NCT07792655
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.
Interested in participating?
Request Info40 year–75 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48108, United States
Location status: Recruiting
Chandramouli Krishnan, PT, PhD
CONTACT
Thomas E Augenstein, MSE, PhD
CONTACT
Persistent hand impairment after stroke is common and can substantially limit independence in daily activities. Access to intensive, task-specific hand therapy is often constrained by travel, cost, and availability of rehabilitation services, leading many individuals to rely on unsupervised home exercise programs. Telerehabilitation supported by low-cost technology may improve access to structured hand training while allowing remote supervision, but its feasibility and implementation in the home setting require systematic evaluation. This study aims to evaluate the feasibility and preliminary effects of a hand telerehabilitation program for individuals with chronic stroke. The study will be conducted as a single-center pilot randomized controlled trial comparing two home-based interventions: (i) telerehabilitation and (ii) a standard home-advice exercise program matched for duration and intensity. Participants randomized to the telerehabilitation group will complete supervised home training sessions using technology-assisted activities to target hand function, delivered remotely via video conferencing. Participants in the control group will follow a home exercise plan similar to that used in typical post-stroke therapy. Outcome measures will be collected before and after the intervention and will include standardized assessments of hand function, as well as measures of adherence and feasibility. This study (i) involves adult stroke survivors, (ii) presents minimal risk, (iii) does not involve deception, (iv) does not collect sensitive health information, and (v) includes brief, noninvasive, and nonpainful interactions consistent with standard rehabilitation activities.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for subjects exposed to Transcranial Magnetic Stimulation (TMS):
Participants 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.
Participants 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.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
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.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
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, with a higher score representing greater arm ability
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
Change in 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. A higher score denotes better self-reported hand function in daily life.
Time frame: Post-intervention (immediately following last session of intervention)
Measure of percentage of sessions completed
Time frame: Post-intervention (within approximately one week of the last session of the intervention)
Subjective feedback regarding feasibility, acceptance, and perceived functional benefits of the intervention
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
Change in the score on the hand section of the upper extremity Fugl-Meyer scale from before the intervention (pre-intervention) to after its completion (post-intervention) using publicly available scoring sheets. The hand section of the Fugl-Meyer scale is a measure of motor impairment in the hand and runs from 0 to 14 points, with higher numbers reflecting better outcome.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
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. Here, a higher ratio indicates improved coordination.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
Change in the Action Research Arm Test Score from before the intervention (pre-intervention) to after its completion (post-intervention) using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
Change in the Nine-hole peg test score from before the intervention (pre-intervention) to after its completion (post-intervention) using publicly available scoring sheets. The Nine-hole peg test is a measure of arm functional ability quantified by the time required to place and remove nine pegs, with a shorter time reflecting better outcome.
Time frame: Pre-intervention and post-intervention measurements will be taken on separate days, within approximately one week of the first and last sessions of the intervention, respectively
Change in corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (pre-intervention) to after its completion (post-intervention).
Contact information is provided by the study sponsor or research team.
Chandramouli Krishnan, PT, PhD
CONTACT
Thomas E Augenstein, MSE, PhD
CONTACT
University of Michigan
Other
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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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