StrokeNCT05204225
Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke
A study testing Tablet Application and Conventional Treatment in people with Stroke and Mobility Limitation, run by University of Seville at 2 sites in 2 countries.
Trial summary
Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Mobility Limitation, Neurologic Disorder
- What is being tested?
- Tablet Application and Conventional Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Jan 2022to 26 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years.
- From 1 week to 6 months after stroke
- Ischemic or hemorrhagic stroke confirmation by computed tomography or magnetic resonance imaging.
- No previous impairments of the upper limb with the stroke affectation.
- Score above 20 on the Minimental State Examination test.
- Alertness and medical stability declared by the responsible neurologist and with ability to follow simple verbal commands
- Ability to move fingers, even partially.
Who cannot join
- Acute traumatic or orthopedic involvement of the limb in concern.
- Unstable medical condition (life expectancy less than 3 months, uncontrolled hypertension, unstable angina, recent myocardial infarction, etc.).
- Any medical condition that may confound interpretation of results or put the patient at risk (e.g. amputated finger, psychiatric illness, etc.).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente, O.U. de Neurología de Rehabilitación
Milan
Spain1 site
Centro de Referencia Estatal de Atención al Daño Cerebral Adquirido (CEADAC)
Madrid, 28034
About this study
Official title: ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand
Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life. Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach. However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of patients with hand affectation after stroke. Thus, current scientific literature advocates transferring such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources. In order to achieve this, telerehabilitation is suggested as one of the most viable formats. However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand specific approach, whose importance is crucial in the recovery of function and autonomy in Activities of Daily Living (ADL). Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback provided, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke. Both health professionals and patients have expressed the need for a specific Tablet application for neurorehabilitation of the hand after stroke, that follows the precepts established by the evidence. However, the lack of specific applications for this approach means that existing apps are used as an adaptation. Therefore, we propose the development and preliminary validation of ReHand, the first Tablet application developed according to the needs of healthcare professionals and patients, and the precepts of the most updated scientific literature, which allows the patient to perform an active therapy adapted to its hand limitations, and the healthcare professional to monitor their patient's home performance.
- Being tested
- Tablet Application, Conventional Treatment
- Medical subject headings
- Stroke, Mobility Limitation, Nervous System Diseases, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet ApplicationOther
Participants will receive a tablet app (ReHand) along with face-to-face physiotherapy sessions. The ReHand app includes an exercise program based on current scientific evidence for improving funcional ability and dexterity of the hand with neurological affectation. Those exercises are performed making controlled taps and movements while touching the touchscreen and guided by feedbacks. Also, ReHand app includes a prescription and monitoring web-based system for professionals. Along with this intervention, face-to-face physiotherapy sessions will be performed their respective centres.
Conventional TreatmentOther
Participants of this group will receive a home exercise program on paper and face-to-face physiotherapy sessions. This intervention is the conventional approach usually delivered in their respective centres. Those exercises were specifically developed for the rehabilitation of the hand with neurological affectation.
| Study group | Role | What they receive |
|---|---|---|
| Tablet Application | Experimental | An exercise program based on the current evidence will be provided through a tablet application (ReHand) along with the face-to-face conventional approach of each recruitment centres. A follow-up of the use of the application will be carried out. The treatment protocol will last 4 weeks, including daily exercise sessions of 30-60 minutes of duration at home though the application tablet. Receives: Other: Tablet Application |
| Conventional Treatment | Active comparator | Participants included in this group will receive the conventional treatment protocol usually prescribed on each recruitment centres. Participants will be asked to perform an exercise program on paper during 4 weeks at home, along with face-to-face sessions. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
A specific scale for the assessment of sensorimotor function of the upper limb after stroke. It includes 33 items, which are rated from 0 to 2 (0 = cannot perform it, 1 = partially perform it, 2 = maximum performance). Its overall score range from 0 to 66. Higher values correspond to greater motor ability.
Measured: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
Secondary outcomes (3)
Dexterity assessed using the Nine Hole Peg Test
Plastic instrument with a shallow round dish to contain pegs and nine holes on the opposite side. It consist of measuring the time spent to place and remove all the pegs from the holes.
Measured: Change from Baseline Nine Hole Peg Test at 4 weeks
Grip strength assessed using a hydraulic grip dynamometer
The Maximum power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer
Measured: Change from Baseline Grip Strength at 4 weeks
Pinch strength assessed using a hydraulic pinch dynamometer
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer.
Measured: Change from Baseline Pinch Strength at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start26 Jan 2022
- Primary completion26 Feb 2022
- Study completion26 Mar 2022
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, Centro de Referencia Estatal de Atención Al Daño Cerebral
- Responsible party
- Principal investigator, Pablo Rodríguez, University of Seville
- Investigators
- Pablo Rodriguez, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204225
- Sponsor's protocol ID
- 825003
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand
- ClinicalTrials.gov ID
- NCT05204225
- Acronym / sponsor ID
- 825003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, Centro de Referencia Estatal de Atención Al Daño Cerebral
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 24 Jan 2022 (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.
Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life. Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach. However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of patients with hand affectation after stroke. Thus, current scientific literature advocates transferring such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources. In order to achieve this, telerehabilitation is suggested as one of the most viable formats. However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand specific approach, whose importance is crucial in the recovery of function and autonomy in Activities of Daily Living (ADL). Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback provided, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke. Both health professionals and patients have expressed the need for a specific Tablet application for neurorehabilitation of the hand after stroke, that follows the precepts established by the evidence. However, the lack of specific applications for this approach means that existing apps are used as an adaptation. Therefore, we propose the development and preliminary validation of ReHand, the first Tablet application developed according to the needs of healthcare professionals and patients, and the precepts of the most updated scientific literature, which allows the patient to perform an active therapy adapted to its hand limitations, and the healthcare professional to monitor their patient's home performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet Application | Experimental | Other: Tablet ApplicationAn exercise program based on the current evidence will be provided through a tablet application (ReHand) along with the face-to-face conventional approach of each recruitment centres. A follow-up of the use of the application will be carried out. The treatment protocol will last 4 weeks, including daily exercise sessions of 30-60 minutes of duration at home though the application tablet. |
| Conventional Treatment | Active comparator | Other: Conventional TreatmentParticipants included in this group will receive the conventional treatment protocol usually prescribed on each recruitment centres. Participants will be asked to perform an exercise program on paper during 4 weeks at home, along with face-to-face sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 18 years.
- From 1 week to 6 months after stroke
- Ischemic or hemorrhagic stroke confirmation by computed tomography or magnetic resonance imaging.
- No previous impairments of the upper limb with the stroke affectation.
- Score above 20 on the Minimental State Examination test.
Key exclusion criteria (3 listed)
- Acute traumatic or orthopedic involvement of the limb in concern.
- Unstable medical condition (life expectancy less than 3 months, uncontrolled hypertension, unstable angina, recent myocardial infarction, etc.).
- Any medical condition that may confound interpretation of results or put the patient at risk (e.g. amputated finger, psychiatric illness, etc.).
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 |
|---|---|---|
| Tablet ApplicationParticipants will receive a tablet app (ReHand) along with face-to-face physiotherapy sessions. The ReHand app includes an exercise program based on current scientific evidence for improving funcional ability and dexterity of the hand with neurological affectation. Those exercises are performed making controlled taps and movements while touching the touchscreen and guided by feedbacks. Also, ReHand app includes a prescription and monitoring web-based system for professionals. Along with this intervention, face-to-face physiotherapy sessions will be performed their respective centres. | Other | Tablet Application |
| Conventional TreatmentParticipants of this group will receive a home exercise program on paper and face-to-face physiotherapy sessions. This intervention is the conventional approach usually delivered in their respective centres. Those exercises were specifically developed for the rehabilitation of the hand with neurological affectation. | Other | Conventional Treatment |
Primary outcome
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
Time frame: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
A specific scale for the assessment of sensorimotor function of the upper limb after stroke. It includes 33 items, which are rated from 0 to 2 (0 = cannot perform it, 1 = partially perform it, 2 = maximum performance). Its overall score range from 0 to 66. Higher values correspond to greater motor ability.
3 secondary outcomes
Dexterity assessed using the Nine Hole Peg Test
Time frame: Change from Baseline Nine Hole Peg Test at 4 weeks
Grip strength assessed using a hydraulic grip dynamometer
Time frame: Change from Baseline Grip Strength at 4 weeks
Pinch strength assessed using a hydraulic pinch dynamometer
Time frame: Change from Baseline Pinch Strength at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Pablo Rodriguez principal investigator
University of Seville
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet Application and Conventional Treatment in people with Stroke and Mobility Limitation, run by University of Seville at 2 sites in 2 countries.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) (time frame: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.). 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 6 Apr 2022.