StrokeNCT05875818
Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients
A study testing In-clinic Rehabilitation and Tele-rehabilitation in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
To determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in 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?
- In-clinic Rehabilitation and Tele-rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 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
- • Patients from both genders.
- Patients with chronic ischemic stroke i.e. 6 months or more.
- Patients with 45 years old and above.
- On modified Ashworth scale, patient with limb spasticity equal to 2 or less than 2.
- On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more.
Who cannot join
- • Patients with any recurrent stroke history.
- Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24)
- Patient having other neurological diseases.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Chaudary Muhammad Akram Teaching Hospital
Lahore, Punjab Province
About this study
Official title: Comparison of Effects of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
To determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in chronic ischemic stroke patients.
- Conditions
- Stroke
- Being tested
- In-clinic Rehabilitation, Tele-rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-clinic RehabilitationDiagnostic test
Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
Tele-rehabilitationDiagnostic test
Effects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation | Other | Not described Receives: Diagnostic Test: Tele-rehabilitation |
| In-clinic Rehabilitation | Experimental | Not described Receives: Diagnostic Test: In-clinic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugal Myer assessment scale (FMAS)
Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke
Measured: 6 Months
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke
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 posted25 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
- 68 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
- NCT05875818
- Sponsor's protocol ID
- DPT/Batch-Fall18/542
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 25 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05875818
- Acronym / sponsor ID
- DPT/Batch-Fall18/542
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 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
- 25 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 determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in 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 |
|---|---|---|
| Tele-rehabilitation | Other | Diagnostic Test: Tele-rehabilitation |
| In-clinic Rehabilitation | Experimental | Diagnostic Test: In-clinic Rehabilitation |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients from both genders.
Key exclusion criteria (3 listed)
- • Patients with any recurrent stroke history.
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 |
|---|---|---|
| In-clinic RehabilitationEffects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients | Diagnostic test | In-clinic Rehabilitation |
| Tele-rehabilitationEffects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients | Diagnostic test | Tele-rehabilitation |
Primary outcome
Fugal Myer assessment scale (FMAS)
Time frame: 6 Months
Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke
Modified Ashworth Scale (MAS)
Time frame: 6 Months
Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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 In-clinic Rehabilitation and Tele-rehabilitation 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 5 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: status not confirmed, as of the sponsor's last update on 25 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 Hina Riaz, DPT (+923364795589, dptm-f18-168@superior.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugal Myer assessment scale (FMAS) (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 25 May 2023.