CVA (Cerebrovascular Accident)NCT05898971
Robotic Hand on Hand Functions in Strokes
A study testing Robotic and Mirror in people with CVA (Cerebrovascular Accident), run by Cairo University at 1 site in Saudi Arabia.
Trial summary
robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident . Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident)
- What is being tested?
- Robotic and Mirror
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Apr 2023to 13 Nov 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spasticity level 1 or 1+ according to modified Ashworth scale
Who cannot join
- Uncontrolled seizures hand fractures or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients
robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident .
Read the detailed description
Post stroke patients aged over 40 years were randomly assigned into three groups (A and B ) Group . Maximum hand grip strength, Hand and Fugl-Meyer Assessment-Upper Extremity (FMA-UE), were assessed at baseline, post-intervention, and six-month follow-up.
- Conditions
- CVA (Cerebrovascular Accident)
- Being tested
- Robotic, Mirror
- Keywords
- Stroke, Hand Grip Strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoboticOther
Patients receive robotic training (grasp and grip)
MirrorOther
Patients receive mirror therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | received robotic gloves training Receives: Other: Robotic |
| Group B | Experimental | received mirror therapy Receives: Other: Mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip strength
Hand Dynamometer will be used to evaluate the hand's grip strength
Measured: 8 weeks, and six-month follow-up.
Hand manual function
Box and block test for measuring the manual dexterity of patients
Measured: 8 weeks, and six-month follow-up.
Secondary outcomes (1)
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
It evaluates sensorimotor impairment
Measured: 8 weeks, and six-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start12 Apr 2023
- Primary completion2 Aug 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Comparative trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Batterjee Medical College
- Responsible party
- Principal investigator, Mariam Elsayed Mohamed Abd Alaal, Cairo University
- Investigators
- Dr. Mariam Salem, Principal investigator, Professor of Physical Therapy , Batterjee Medical College.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898971
- Sponsor's protocol ID
- BMC
- Status last verified
- Sep 2023
- First submitted
- 21 May 2023
- Last updated
- 11 Jun 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT05898971
- Acronym / sponsor ID
- BMC
- Conditions
- CVA (Cerebrovascular Accident)
- Keywords
- Stroke, Hand Grip Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Batterjee Medical College
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 12 Jun 2023 (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.
robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident .
Detailed description
Post stroke patients aged over 40 years were randomly assigned into three groups (A and B ) Group . Maximum hand grip strength, Hand and Fugl-Meyer Assessment-Upper Extremity (FMA-UE), were assessed at baseline, post-intervention, and six-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Comparative trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Roboticreceived robotic gloves training |
| Group B | Experimental | Other: Mirrorreceived mirror therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spasticity level 1 or 1+ according to modified Ashworth scale
Key exclusion criteria (1 listed)
- Uncontrolled seizures hand fractures or surgery
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 |
|---|---|---|
| RoboticPatients receive robotic training (grasp and grip) | Other | Group A |
| MirrorPatients receive mirror therapy | Other | Group B |
Primary outcome
hand grip strength
Time frame: 8 weeks, and six-month follow-up.
Hand Dynamometer will be used to evaluate the hand's grip strength
Hand manual function
Time frame: 8 weeks, and six-month follow-up.
Box and block test for measuring the manual dexterity of patients
1 secondary outcome
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time frame: 8 weeks, and six-month follow-up.
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Dr. Mariam Salem principal investigator
Professor of Physical Therapy , Batterjee Medical College.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic and Mirror in people with CVA (Cerebrovascular Accident), run by Cairo University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 11 Jun 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 Saudi Arabia. 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?
hand grip strength (time frame: 8 weeks, and six-month follow-up.). The study lists 2 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 11 Jun 2025.