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R3THA Rehabilitation Feasibility and Usability Study

R3THA Rehabilitation Feasibility and Usability Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06854978
Acronym
RETHA
Enrollment
10
Registered
2025-03-03
Start date
2024-03-27
Completion date
2026-03-25
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

OTHERRETHA

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.

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Kinematic Assessment5 weeksKinematic assesment to measure range of motion of the hand and arm
System Usability Survey5 weeksSystem Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.
Exergame Questionnaire5 weeksIt is a questionnaire developed to assess qualitative performance of the device
Performance Survey5 weeksIt is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.
Fugl-Meyer Assessment for Upper Extremity5 weeksA standard clinical measure to assess the level of motor impairment in individuals with stroke.
Box and Blocks Test5 weeksbox and blocks test is standard measure for hand dexterity and hand-eye coordination
Action Research Arm Test5 weeksThe standard assessment for functional performance in individuals with stroke

Secondary

MeasureTime frameDescription
Montreal Cognitive Assessment Test (MOCA)1 week30-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

Countries

United States

Contacts

Primary ContactKiran Karunakaran, PhD
kkarunakaran@kesslerfoundation.org973-324-3590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026