StrokeNCT05397366
Comparison of TSTVs NT Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
A study testing Task Specific Training and Neurodevelopmental Training in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
Comparison of Task Specific Training Vs Neurodevelopmental Training Along with Conventional Therapy for Upper Limb Motor Function Among Chronic 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?
- Task Specific Training and Neurodevelopmental Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 31 May 2022to Oct 2022
- 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
- Chronic ischemic stroke patients( after 3 months of stroke ).(41)
- Patients from both gender.(42)
- Patients of around age of 45-65.(43)
- Patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44)
- Patient with good cognitive function minimum 20 or more on Mini Mental State Examination (MMSE).(45)
Who cannot join
- Patients with history of the recurrent stroke.(41)
- Patient with fracture or dislocation of upper limb.(46)
- Patient with any peripheral vascular disease (47)
- Patient with any comorbid neurological disease like Parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21)
- Patient with skin discoloration, skin ulcers and skin allergy.(48)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shadman Medical Centre Chaudhry Muhammad Akram Teaching and Research Hospital University of Lahore Teaching Hospital Services Hospital Lahore General Hospital Bashir Neuro Supine Institute
Lahore
About this study
Official title: Comparison of Task Specific Training Vs Neurodevelopmental Training Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Comparison of Task Specific Training Vs Neurodevelopmental Training Along with Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Read the detailed description
To compare Task Specific Training versus Neurodevelopmental Training along with conventional therapy for upper limb motor function among chronic stroke patients.
- Conditions
- Stroke
- Being tested
- Task Specific Training, Neurodevelopmental Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Specific TrainingDiagnostic test
Group A will be given Task Specific protocol with routine physical therapy treatment for 45 mins on the upper limb for 3 days a week for a period of 12 weeks.
This Task Specific protocol will include different exercises like, do the polishing of the table top , can perform arm cradling, can supinate and pronate the cylindrical object with arm , while pushing the cylindrical object can extend the wrist , can reach forward to touch or to pick an object , can bend side ways to pick the object and place it on the table in front , can pour the 1/2cup of water to the wide jar that is held by the patient in other hand , patient can comb his hair , patient can drink and eat independently , can lift the jar and bring it close to lips , can pick up pen by using thumb and two fingers , can do the stacking checkers , can throw a ball into the basket , can push the ball on wall from front and side.
Neurodevelopmental TrainingDiagnostic test
Group B will receive the Neurodevelopmental protocol with the routine physical therapy for 45 mins on the upper limb 3 times a week for period of 12 weeks. The intervention will be performed by the trained physical therapist.
This Neurodevelopmental protocol will include different exercises like , patient should sit while bearing weight , patient can do self-overhead movements with hand clasped , while holding the gymnastic ball reach forward and overhead position while sitting , weight bearing while plantigrade or quadruped position , while sitting or standing can move the ball in forward , backward and sideways.
| Study group | Role | What they receive |
|---|---|---|
| Task Specific Training | Experimental | Using Task Specific Training Receives: Diagnostic Test: Task Specific Training |
| Neurodevelopmental Training | Experimental | Using Neurodevelopmental Training Receives: Diagnostic Test: Neurodevelopmental Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Training
37 will receive Neurodevelopmental treatment is based on the premise that the presence of normal postural reflex mechanisms is fundamental to a motor skill's performance. Mini mental state examination test
Measured: 6 Months
Secondary outcomes (1)
Task Specific Training
37 will receive Task specific training is a type of exercise treatment involving repeated practise with your affected arm/hand. Wolf Motor Function Test (WMFT)
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 posted31 May 2022
- Study start31 May 2022
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (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
- 74 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
- NCT05397366
- Sponsor's protocol ID
- DPT/Batch-Fall17/510
- Status last verified
- Jun 2022
- First submitted
- 10 May 2022
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Task Specific Training Vs Neurodevelopmental Training Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05397366
- Acronym / sponsor ID
- DPT/Batch-Fall17/510
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 31 May 2022 (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.
Comparison of Task Specific Training Vs Neurodevelopmental Training Along with Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Detailed description
To compare Task Specific Training versus Neurodevelopmental Training along with conventional therapy for upper limb motor function among chronic 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 |
|---|---|---|
| Task Specific Training | Experimental | Diagnostic Test: Task Specific TrainingUsing Task Specific Training |
| Neurodevelopmental Training | Experimental | Diagnostic Test: Neurodevelopmental TrainingUsing Neurodevelopmental Training |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic ischemic stroke patients( after 3 months of stroke ).(41)
- Patients from both gender.(42)
- Patients of around age of 45-65.(43)
- Patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44)
- Patient with good cognitive function minimum 20 or more on Mini Mental State Examination (MMSE).(45)
Key exclusion criteria (5 listed)
- Patients with history of the recurrent stroke.(41)
- Patient with fracture or dislocation of upper limb.(46)
- Patient with any peripheral vascular disease (47)
- Patient with any comorbid neurological disease like Parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21)
- Patient with skin discoloration, skin ulcers and skin allergy.(48)
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 |
|---|---|---|
| Task Specific TrainingGroup A will be given Task Specific protocol with routine physical therapy treatment for 45 mins on the upper limb for 3 days a week for a period of 12 weeks. This Task Specific protocol will include different exercises like, do the polishing of the table top , can perform arm cradling, can supinate and pronate the cylindrical object with arm , while pushing the cylindrical object can extend the wrist , can reach forward to touch or to pick an object , can bend side ways to pick the object and place it on the table in front , can pour the 1/2cup of water to the wide jar that is held by the patient in other hand , patient can comb his hair , patient can drink and eat independently , can lift the jar and bring it close to lips , can pick up pen by using thumb and two fingers , can do the stacking checkers , can throw a ball into the basket , can push the ball on wall from front and side. | Diagnostic test | Task Specific Training |
| Neurodevelopmental TrainingGroup B will receive the Neurodevelopmental protocol with the routine physical therapy for 45 mins on the upper limb 3 times a week for period of 12 weeks. The intervention will be performed by the trained physical therapist. This Neurodevelopmental protocol will include different exercises like , patient should sit while bearing weight , patient can do self-overhead movements with hand clasped , while holding the gymnastic ball reach forward and overhead position while sitting , weight bearing while plantigrade or quadruped position , while sitting or standing can move the ball in forward , backward and sideways. | Diagnostic test | Neurodevelopmental Training |
Primary outcome
Neurodevelopmental Training
Time frame: 6 Months
37 will receive Neurodevelopmental treatment is based on the premise that the presence of normal postural reflex mechanisms is fundamental to a motor skill's performance. Mini mental state examination test
1 secondary outcome
Task Specific Training
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 9 Jun 2022.
- 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.
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 Task Specific Training and Neurodevelopmental Training 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 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: status not confirmed, as of the sponsor's last update on 9 Jun 2022. 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?
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?
Neurodevelopmental Training (time frame: 6 Months). 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 9 Jun 2022.