NCT06854978

Brief Summary

The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable stroke

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

Study Start

First participant enrolled

March 27, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 25, 2025

Last Update Submit

February 28, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

  • System Usability Survey

    System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.

    5 weeks

  • Exergame Questionnaire

    It is a questionnaire developed to assess qualitative performance of the device

    5 weeks

  • Performance Survey

    It is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.

    5 weeks

  • Fugl-Meyer Assessment for Upper Extremity

    A standard clinical measure to assess the level of motor impairment in individuals with stroke.

    5 weeks

  • Box and Blocks Test

    box and blocks test is standard measure for hand dexterity and hand-eye coordination

    5 weeks

  • Action Research Arm Test

    The standard assessment for functional performance in individuals with stroke

    5 weeks

  • Kinematic Assessment

    Kinematic assesment to measure range of motion of the hand and arm

    5 weeks

Secondary Outcomes (1)

  • Montreal Cognitive Assessment Test (MOCA)

    1 week

Study Arms (1)

Stroke

EXPERIMENTAL

The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.

Other: RETHA

Interventions

RETHAOTHER

The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.

Stroke

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be between the ages of 20 and 80
  • must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
  • must have internet access at home.
  • must be comfortable performing basic functions on a computer, such as browsing the internet.
  • must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.

You may not qualify if:

  • Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.
  • \) Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kiran Karunakaran, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiran Karunakaran, PhD

CONTACT

973-324-3590kkarunakaran@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

March 27, 2024

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)