StrokeRETHANCT06854978
R3THA Rehabilitation Feasibility and Usability Study
A study testing RETHA in people with Stroke, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- RETHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Kiran Karunakaran, PhD, 973-324-3590, kkarunakaran@kesslerfoundation.org
About this study
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
- Being tested
- RETHA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETHAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | 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. Receives: Other: RETHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Survey
System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.
Measured: 5 weeks
Exergame Questionnaire
It is a questionnaire developed to assess qualitative performance of the device
Measured: 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.
Measured: 5 weeks
Fugl-Meyer Assessment for Upper Extremity
A standard clinical measure to assess the level of motor impairment in individuals with stroke.
Measured: 5 weeks
Box and Blocks Test
box and blocks test is standard measure for hand dexterity and hand-eye coordination
Measured: 5 weeks
Action Research Arm Test
The standard assessment for functional performance in individuals with stroke
Measured: 5 weeks
Kinematic Assessment
Kinematic assesment to measure range of motion of the hand and arm
Measured: 5 weeks
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Mar 2024
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Karunakaran, Kessler Foundation
- Investigators
- Kiran Karunakaran, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854978
- Sponsor's protocol ID
- R-1258-24
- Other IDs
- 2226174
- Acronym
- RETHA
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R3THA Rehabilitation Feasibility and Usability Study
- ClinicalTrials.gov ID
- NCT06854978
- Acronym / sponsor ID
- RETHA / R-1258-24
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Other: RETHAThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RETHAThe 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 | Stroke |
Primary outcome
System Usability Survey
Time frame: 5 weeks
System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.
Exergame Questionnaire
Time frame: 5 weeks
It is a questionnaire developed to assess qualitative performance of the device
Performance Survey
Time frame: 5 weeks
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.
Fugl-Meyer Assessment for Upper Extremity
Time frame: 5 weeks
A standard clinical measure to assess the level of motor impairment in individuals with stroke.
Box and Blocks Test
Time frame: 5 weeks
box and blocks test is standard measure for hand dexterity and hand-eye coordination
Action Research Arm Test
Time frame: 5 weeks
The standard assessment for functional performance in individuals with stroke
Kinematic Assessment
Time frame: 5 weeks
Kinematic assesment to measure range of motion of the hand and arm
1 secondary outcome
Montreal Cognitive Assessment Test (MOCA)
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiran Karunakaran, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETHA in people with Stroke, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiran Karunakaran, PhD (973-324-3590, kkarunakaran@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Survey (time frame: 5 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.