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Recruiting NCT06854978

R3THA Rehabilitation Feasibility and Usability Study

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RETHA.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Montreal Cognitive Assessment Test (MOCA) [Time frame: 1 week]

Eligibility criteria

Inclusion criteria

  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kessler Foundation — West Orange

Identifiers

NCT: NCT06854978 · R-1258-24 · 2226174

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗