R3THA Rehabilitation Feasibility and Usability Study

NCT ID: NCT06854978

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2026-03-25

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RETHA

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Kiran Karunakaran

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kiran Karunakaran, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kiran Karunakaran, PhD

Role: CONTACT

kkarunakaran@kesslerfoundation.org

973-324-3590

Facility Contacts

Kiran Karunakaran, PhD

Role: primary

kkarunakaran@kesslerfoundation.org

973-324-3590

Other Identifiers

2226174

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R-1258-24

Identifier Type: -

Identifier Source: org_study_id