Strokes ThromboticCIMTNCT06485583
Comparison Between the Efficacy of CIMT and NDT Along With Conventional Physiotherapy Treatment on Upper Extremity Rehabilitation Among Patients of Stroke
A study testing Constraint-induced movement therapy and Neurodevelopmental Treatment in people with Strokes Thrombotic, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Strokes Thrombotic
- What is being tested?
- Constraint-induced movement therapy and Neurodevelopmental Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2024to 29 Jan 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 23.
Who cannot join
- Participants with visual or auditory deficits, musculoskeletal (MSK) disorders, mental impairments, or a history of surgery will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ayesha Fatima
Lahore, Punjab Province, 54000
JAVERIYA ASLAM, 03119353656
MASOOMA GULL, 03244283378, masoomagull2@ymail.com
About this study
To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation
Read the detailed description
This research aims to provide a comprehensive comparison of CIMT and NDT, supplemented by conventional physiotherapy, in the rehabilitation of upper extremity function among stroke patients. The findings will inform clinical practice, guiding the development of optimized, patient-centered rehabilitation strategies.
- Conditions
- Strokes Thrombotic
- Being tested
- Constraint-induced movement therapy, Neurodevelopmental Treatment
- Keywords
- (CIMT), (NDT)
- Medical subject headings
- Thrombotic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced movement therapyOther
is a rehabilitation technique used to improve motor function in people who have had a stroke or other neurological conditions. CIMT restricts the use of the unaffected limb, typically with a mitt or sling, to encourage the use of the affected limb.
Neurodevelopmental TreatmentOther
Therapy, is a rehabilitation approach used to address movement and motor control deficits in people with neurological illnesses such as stroke, cerebral palsy, or traumatic brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Constraint-Induced Movement Therapy | Other | The rehabilitation plan involves several components to promote the recovery of the affected limb. Initially, we will immobilize the unaffected limb using a constraint device such as a mitt or sling for about 90% of waking hours over a period of six weeks. Receives: Other: Constraint-induced movement therapy |
| neurodevelopmental treatment | Other | The rehabilitation approach includes hands-on techniques to guide the patient through normal movement patterns. By providing sensory input, we aim to improve motor control and postural alignment, using techniques such as handling, guiding, and assisting movements. Receives: Other: Neurodevelopmental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity rehabilitation
The Motor Assessment Scale (MAS) by Carr and Shepherd is a clinical tool used to evaluate upper extremity rehabilitation in stroke patients. It assesses motor recovery through eight items, each reflecting daily activities, scored on a 7-point scale from 0 (unable to perform) to 6 (optimal performance). For upper extremity assessment, the MAS includes tasks like hand movements (grasping, releasing, manipulating objects), advanced hand activities (fine motor skills such as writing or buttoning a shirt), and upper arm function (reaching, lifting, placing objects). Patients perform these tasks while clinicians observe and score their performance. The MAS provides a quantitative measure of motor recovery, facilitating progress tracking, goal setting, and personalized therapy interventions, making it a reliable and straightforward tool for capturing functional changes in stroke patients.
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 posted3 Jul 2024
- Study start28 Jun 2024 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion29 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Strokes ThromboticStudies 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
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayesha fatima, Shalamar Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485583
- Sponsor's protocol ID
- ShalamarIHR
- Acronym
- CIMT
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. The Lancet Neurology. 201514(2):224-34. 2. Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to Page 5 of 7 treat motor disorders. Progress in brain research. 2013207:379-401. 3. Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, et al. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Frontiers in neurology. 202112:622014. 4. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research. 197512(3):189-98. 5. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 198767(2):206-7. 6. Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 198565(2):175-80. 7. Ahn SY, Bok S-K, Lee JY, Ryoo HW, Lee HY, Park HJ, et al. Benefits of Robot-Assisted Upper-Limb Rehabilitation from the Subacute Stage after a Stroke of Varying Severity: A Multicenter Randomized Controlled Trial. Journal of Clinical Medicine. 202413(3):808. 8. Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, et al. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016315(6):571-81. 9. Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia. Developmental medicine and child neurology. 201153(4):313-20.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of CIMT and NDT Along With Conventional Physiotherapy Treatment on Upper Extremity Rehabilitation Among Patients of Stroke
- ClinicalTrials.gov ID
- NCT06485583
- Acronym / sponsor ID
- CIMT / ShalamarIHR
- Conditions
- Strokes Thrombotic
- Keywords
- (CIMT), (NDT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 28 Jun 2024 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 29 Jan 2025 (estimated)
- First posted
- 3 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.
To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation
Detailed description
This research aims to provide a comprehensive comparison of CIMT and NDT, supplemented by conventional physiotherapy, in the rehabilitation of upper extremity function among stroke patients. The findings will inform clinical practice, guiding the development of optimized, patient-centered rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-Induced Movement Therapy | Other | Other: Constraint-induced movement therapyThe rehabilitation plan involves several components to promote the recovery of the affected limb. Initially, we will immobilize the unaffected limb using a constraint device such as a mitt or sling for about 90% of waking hours over a period of six weeks. |
| neurodevelopmental treatment | Other | Other: Neurodevelopmental TreatmentThe rehabilitation approach includes hands-on techniques to guide the patient through normal movement patterns. By providing sensory input, we aim to improve motor control and postural alignment, using techniques such as handling, guiding, and assisting movements. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 23.
Key exclusion criteria (1 listed)
- Participants with visual or auditory deficits, musculoskeletal (MSK) disorders, mental impairments, or a history of surgery will be excluded from the study.
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 |
|---|---|---|
| Constraint-induced movement therapyis a rehabilitation technique used to improve motor function in people who have had a stroke or other neurological conditions. CIMT restricts the use of the unaffected limb, typically with a mitt or sling, to encourage the use of the affected limb. | Other | Constraint-Induced Movement Therapy |
| Neurodevelopmental TreatmentTherapy, is a rehabilitation approach used to address movement and motor control deficits in people with neurological illnesses such as stroke, cerebral palsy, or traumatic brain injury. | Other | neurodevelopmental treatment |
Primary outcome
upper extremity rehabilitation
Time frame: 6 WEEKS
The Motor Assessment Scale (MAS) by Carr and Shepherd is a clinical tool used to evaluate upper extremity rehabilitation in stroke patients. It assesses motor recovery through eight items, each reflecting daily activities, scored on a 7-point scale from 0 (unable to perform) to 6 (optimal performance). For upper extremity assessment, the MAS includes tasks like hand movements (grasping, releasing, manipulating objects), advanced hand activities (fine motor skills such as writing or buttoning a shirt), and upper arm function (reaching, lifting, placing objects). Patients perform these tasks while clinicians observe and score their performance. The MAS provides a quantitative measure of motor recovery, facilitating progress tracking, goal setting, and personalized therapy interventions, making it a reliable and straightforward tool for capturing functional changes in stroke patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background1. Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. The Lancet Neurology. 201514(2):224-34. 2. Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to Page 5 of 7 treat motor disorders. Progress in brain research. 2013207:379-401. 3. Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, et al. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Frontiers in neurology. 202112:622014. 4. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research. 197512(3):189-98. 5. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 198767(2):206-7. 6. Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 198565(2):175-80. 7. Ahn SY, Bok S-K, Lee JY, Ryoo HW, Lee HY, Park HJ, et al. Benefits of Robot-Assisted Upper-Limb Rehabilitation from the Subacute Stage after a Stroke of Varying Severity: A Multicenter Randomized Controlled Trial. Journal of Clinical Medicine. 202413(3):808. 8. Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, et al. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016315(6):571-81. 9. Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia. Developmental medicine and child neurology. 201153(4):313-20.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-induced movement therapy and Neurodevelopmental Treatment in people with Strokes Thrombotic, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
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: status not confirmed, as of the sponsor's last update on 3 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper extremity rehabilitation (time frame: 6 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485583, which also lists 1 linked publication.
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 Jul 2024.