Recruiting

R3THA

Sponsor:

Kessler Foundation

Code:

NCT06854978

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

RETHA

Study Details

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 ID

NCT06854978

Start date

Mar 27, 2024

Status verified date

Feb, 2025

Completion date

Mar 25, 2026

Anticipated

Primary completion date

Mar 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • System Usability Survey [ Time Frame: 5 weeks ]
  • Exergame Questionnaire [ Time Frame: 5 weeks ]
  • Performance Survey [ Time Frame: 5 weeks ]
  • Fugl-Meyer Assessment for Upper Extremity [ Time Frame: 5 weeks ]
  • Box and Blocks Test [ Time Frame: 5 weeks ]
  • Action Research Arm Test [ Time Frame: 5 weeks ]
  • Kinematic Assessment [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 3, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-03-03.