StrokeNCT06520748
IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN STROKE
A study testing Hand rehabilitation program using the computerized glove and Selected hand program in people with Stroke, run by Ahmed Alshimy at 1 site in Egypt.
Trial summary
Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Hand rehabilitation program using the computerized glove and Selected hand program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2023to 3 Apr 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
- Duration of illness ranges from (6weeks to 6 months) after stroke onset.
- first stroke.
- Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
- With a minimum 10° extension and/or flexion of the wrist or fingers, an ability to flex and extend the wrist joint five times continuously without losing active range of motion.
Who cannot join
- apraxia or hemianopsia.
- diabetic polyneuropathy.
- Aphasia , cognitive deficits.
- a previous disability in the upper limbs, tactile agnosia (stereognosis).
- LT hemiplegia, Post Botox injection, recurrent stroke, and Posterior parietal lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN PATIENT WITH STROKE
Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.
Read the detailed description
Thirty male/female stroke patients in the sub-acute phase were randomly assigned in to the two groups (study and control) in sets of three. The study group (A) (n = 15) underwent a hand rehabilitation program using the computerized glove combined with the selected hand program. The control group (B) (n = 15) received only the selected hand program. The treatment schedules for 18 consecutive treatment sessions, three times per week.
- Conditions
- Stroke
- Being tested
- Hand rehabilitation program using the computerized glove, Selected hand program
- Keywords
- Stroke, Hand recovery, Plasticity, Computerized glove
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand rehabilitation program using the computerized gloveOther
The patient extended finger to reach from grey to green to red colour and heard the beep providing knowledge of result (KR), whereas the increase of range of finger extension reached every session provides knowledge of performance (KP). As the patient's performance improved, the range of their finger's movement will also be increased due to the augmented feedback provided to the patient and the therapist through the glove software
Selected hand programOther
Distal key point of Bobath, approximation of affected arm, to control spasticity of wrist/ finger flexor (5 minutes). Dynamic splint to facilitate wrist and finger extension (10 repeat*5 sets). Passive range of motion exercise (10 repeat*5 sets) for each joint. Mud exercise (spherical, clyndrical , hook). Thera band exercises.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | underwent a hand rehabilitation program using the computerized glove combined with the selected hand program Receives: Other: Hand rehabilitation program using the computerized glove; Other: Selected hand program |
| Control Group | Experimental | received only the selected hand program Receives: Other: Selected hand program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitive Electro Encephalo Graphy
Used to assess Neuralplasticity (sleep Delta - Delta/Beta ratio )
Measured: 6 weeks
Computerized glove software
Used to assess the Kinematic Data (Thumb, Index, Middle, ring, little, and average range of motion)
Measured: 6 weeks
Action Research Arm Test
Used to assess Fine manual dexterity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start5 Oct 2023
- Primary completion6 Feb 2024
- Study completion3 Apr 2024
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Alshimy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Alshimy, AlRyada University for Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520748
- Sponsor's protocol ID
- P.T.REC/012/004602
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 25 Jul 2024
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN PATIENT WITH STROKE
- ClinicalTrials.gov ID
- NCT06520748
- Acronym / sponsor ID
- P.T.REC/012/004602
- Conditions
- Stroke
- Keywords
- Stroke, Hand recovery, Plasticity, Computerized glove
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmed AlshimyUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 25 Jul 2024 (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.
Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.
Detailed description
Thirty male/female stroke patients in the sub-acute phase were randomly assigned in to the two groups (study and control) in sets of three. The study group (A) (n = 15) underwent a hand rehabilitation program using the computerized glove combined with the selected hand program. The control group (B) (n = 15) received only the selected hand program. The treatment schedules for 18 consecutive treatment sessions, three times per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Hand rehabilitation program using the computerized glove, Other: Selected hand programunderwent a hand rehabilitation program using the computerized glove combined with the selected hand program |
| Control Group | Experimental | Other: Selected hand programreceived only the selected hand program |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
- Duration of illness ranges from (6weeks to 6 months) after stroke onset.
- first stroke.
- Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
- With a minimum 10° extension and/or flexion of the wrist or fingers, an ability to flex and extend the wrist joint five times continuously without losing active range of motion.
Key exclusion criteria (5 listed)
- apraxia or hemianopsia.
- diabetic polyneuropathy.
- Aphasia , cognitive deficits.
- a previous disability in the upper limbs, tactile agnosia (stereognosis).
- LT hemiplegia, Post Botox injection, recurrent stroke, and Posterior parietal lesion.
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 |
|---|---|---|
| Hand rehabilitation program using the computerized gloveThe patient extended finger to reach from grey to green to red colour and heard the beep providing knowledge of result (KR), whereas the increase of range of finger extension reached every session provides knowledge of performance (KP). As the patient's performance improved, the range of their finger's movement will also be increased due to the augmented feedback provided to the patient and the therapist through the glove software | Other | Study Group |
| Selected hand programDistal key point of Bobath, approximation of affected arm, to control spasticity of wrist/ finger flexor (5 minutes). Dynamic splint to facilitate wrist and finger extension (10 repeat*5 sets). Passive range of motion exercise (10 repeat*5 sets) for each joint. Mud exercise (spherical, clyndrical , hook). Thera band exercises. | Other | Control Group, Study Group |
Primary outcome
Quantitive Electro Encephalo Graphy
Time frame: 6 weeks
Used to assess Neuralplasticity (sleep Delta - Delta/Beta ratio )
Computerized glove software
Time frame: 6 weeks
Used to assess the Kinematic Data (Thumb, Index, Middle, ring, little, and average range of motion)
Action Research Arm Test
Time frame: 6 weeks
Used to assess Fine manual dexterity
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 25 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand rehabilitation program using the computerized glove and Selected hand program in people with Stroke, run by Ahmed Alshimy at 1 site in Egypt.
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 5 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 25 Jul 2024. 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 Egypt. 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?
Quantitive Electro Encephalo Graphy (time frame: 6 weeks). The study lists 3 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 25 Jul 2024.