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NCT Number: NCT07792655

Telerehabilitation for Post-Stroke Hand Function

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.

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Key information

Conditions

Stroke Asthenia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011

Ann Arbor, Michigan, 48108, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • Recent history of significant spatial neglect
  • Joint contractures or significant spasticity in the hand
  • History of a recent Botulinum Toxin (Botox) injection to the upper-extremity muscles (≤ 3 months)
  • Pregnant or actively planning to become pregnant (self-reported)
  • Inability to communicate or unable to consent

Exclusion criteria

for subjects exposed to Transcranial Magnetic Stimulation (TMS):

  • Unable to obtain reliable motor evoked potentials
  • Recent history of repeated fainting spells or syncope.
  • Recent history of seizure while on anti-seizure medication
  • Recent history of skull fracture/head injury
  • Ferromagnetic metal implants in the skull
  • Cochlear implant
  • Implanted deep brain stimulator
  • Implanted vagus nerve stimulator
  • Implanted cervical spine epidural stimulator
  • Ventriculoperitoneal shunt
  • Skull defect related to the current stroke
  • Previous serious adverse reaction to TMS
  • Implanted electronic cardiac device (e.g., cardiac pacemaker)

Treatment and study plan

Technology-Supported Hand Training

Behavioral

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.

Pamphlet-Supported Hand Activity

Behavioral

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.

Primary outcomes

  1. Hand Spread

    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)

    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

  2. Box and Block Test Score

    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)

    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

  3. Stroke Impact Scale-Hand Score

    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)

    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.

Other outcomes

  1. Adherence

    Time frame: Post-intervention (immediately following last session of intervention)

    Measure of percentage of sessions completed

  2. Qualitative Survey

    Time frame: Post-intervention (an average of up to 1 week after completion of the 6-week intervention)

    Subjective feedback regarding feasibility, acceptance, and perceived functional benefits of the intervention. The qualitative survey has no scale.

  3. Upper extremity Fugl-Meyer Score (Hand Section) Score

    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)

    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.

  4. Principal Component Ratio

    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)

    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.

  5. Action Research Arm Test Score

    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)

    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 functional ability of the arm.

  6. Nine-Hole Peg Test Score

    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)

    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. Times of the test can vary from 0 to no upper limit with a smaller time reflecting better functional ability of the arm.

  7. Corticospinal Excitability

    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)

    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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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