StrokeNCT05854121
FES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients
A study testing Functional Electrical Stimulation and Constrained Induced Movement Therapy in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
To determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Electrical Stimulation and Constrained Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Aug 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale.
- Patients having active cognitive scoring on Mini Mental State Examination.
Who cannot join
- Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shadman Medical Care
Lahore, Punjab Province
About this study
Official title: Functional Electrical Stimulation Versus Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
To determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
- Conditions
- Stroke
- Being tested
- Functional Electrical Stimulation, Constrained Induced Movement Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDiagnostic test
Functional Electrical Stimulation for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Constrained Induced Movement TherapyDiagnostic test
Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | Other | Not described Receives: Diagnostic Test: Functional Electrical Stimulation |
| Constrained Induced Movement Therapy | Experimental | Not described Receives: Diagnostic Test: Constrained Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale Modified Ash worth
Measured: 6 Months
Motor Function assessment test
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2023 (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 Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854121
- Sponsor's protocol ID
- DPT/Batch-Fall18/531
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Versus Constrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05854121
- Acronym / sponsor ID
- DPT/Batch-Fall18/531
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 May 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.
To determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | Other | Diagnostic Test: Functional Electrical Stimulation |
| Constrained Induced Movement Therapy | Experimental | Diagnostic Test: Constrained Induced Movement Therapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale.
- Patients having active cognitive scoring on Mini Mental State Examination.
Key exclusion criteria (1 listed)
- Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.
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 |
|---|---|---|
| Functional Electrical StimulationFunctional Electrical Stimulation for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients | Diagnostic test | Functional Electrical Stimulation |
| Constrained Induced Movement TherapyConstrained Induced Movement Therapy for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients | Diagnostic test | Constrained Induced Movement Therapy |
Primary outcome
Scale Modified Ash worth
Time frame: 6 Months
Motor Function assessment test
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation and Constrained Induced Movement Therapy in people with Stroke, run by Superior University 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 2 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 11 May 2023. 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?
Contact Salwa Jamil, DPT (+923209458491, Salwajamil998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale Modified Ash worth (time frame: 6 Months). 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 May 2023.