R3THA Rehabilitation Feasibility and Usability Study (RETHA)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: RETHA

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiran Karunakaran, PhD; Phone Number: 973-324-3590; Email: kkarunakaran@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Kiran Karunakaran, PhD; Phone Number: 973-324-3590; Email: kkarunakaran@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.

2) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment Test (MOCA)	30-item question to assess cognitive impairment in people with stroke. The score ranges from 0 to maximum score of 30. Score of 30 denotes high cognitive function while 0 is low cognitive function	1 week

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Kiran Karunakaran, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): March 25, 2026
• Study Completion (Estimated): March 25, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: R-1258-24; 2226174 (Other Grant/Funding Number: NSF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No