NCT07792655

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
16mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2028

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

handupper extremitystroke survivorsarmhemiparesisweaknessfingerindividuation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

  • 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, with a higher score representing greater arm ability

    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

  • Stroke Impact Scale-Hand Score

    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.

    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

Other Outcomes (7)

  • Adherence

    Post-intervention (immediately following last session of intervention)

  • Qualitative Survey

    Post-intervention (within approximately one week of the last session of the intervention)

  • Upper extremity Fugl-Meyer Score (Hand Section) Score

    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

  • +4 more other outcomes

Study Arms (2)

Technology-Supported Hand Training Group

EXPERIMENTAL

Participants will undergo a remotely delivered, technology-supported hand training program that involves guided hand activities in 18 sessions over 6 weeks

Behavioral: Technology-Supported Hand Training

Pamphlet-Supported Hand Activity Group

ACTIVE COMPARATOR

Participants will undergo home therapy intervention guided by an advice plan created using typical occupational therapy guidance that includes 18 sessions over 6 weeks

Behavioral: Pamphlet-Supported Hand Activity

Interventions

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.

Technology-Supported Hand Training Group

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.

Pamphlet-Supported Hand Activity Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011

Ann Arbor, Michigan, 48108, United States

RECRUITING

MeSH Terms

Conditions

StrokeParesisAsthenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas E Augenstein, MSE, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Chandramouli Krishnan, PT, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas E Augenstein, MSE, PhD

CONTACT

Chandramouli Krishnan, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two parallel intervention groups: a technology-enabled telerehabilitation program or a standard home exercise program matched for duration and intensity. Outcomes will be assessed before and after the intervention to compare feasibility, adherence, and changes in hand function between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow, Physical Medicine and Rehabilitation, Medical School

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 28, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 7, 2028

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations