Chronic StrokeNCT06131827
Neural Mobilization With Task Based Activities on Upper Limb in Patients With Chronic Stroke.
A study testing Neural mobilization and Task based activities in people with Chronic Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Neural mobilization and Task based activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jul 2023to 22 Jan 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female stroke patients.
- 6 month to one year post stroke .
- Age 30-55
- Stable patients
- Mini - mental state examination>2
- Modified ashworth Scale equal<+1
Who cannot join
- Orthopedic deformity
- Patients undergo bottulinuminjection toxin injection
- Visual impairments
- Joint pain (elbow, shoulder, wrist)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ripha international university
Lahore, Punjab Province, 5433
Memona Ayesha, Ms-NMPT, 03129601249, memonaayesha66@gmail.com
Asrar Yousaf, 030040995505, asrar.yousaf@riphah.edu.pk
About this study
Official title: Combined Effects of Neural Mobilization With Task Based Activities on Spasticity and Motor Function of Upper Limb in Patients With Chronic Stroke.
Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. In this study we use two techniques to improve upper limb motor dysfunction and reduce spasticity. One is task-based activities which is used to improve motor function and focus on active participation rather than normal movement pattern and other is neural mobilization which aims to reduce spasticity which is most common in stroke patients.
Read the detailed description
This study will be randomized controlled trial. Participants having stroke past 6 month to 1 year and mini mental state examination score >21 will be included in this study. And participants with severe orthopedic deformity, joint pain and visual impairment will be excluded from this study. The sample size will consist of 34 participants selected through non probability convenient sampling technique, which will further be randomized through sealed envelope method and will divide into two groups .Data will be collected using assessment tools, including the Fugl Mayer assessment scale, box and block test and wolf motor function test. 17 Participants will be assigned to the interventional group (A )which will undergo neural mobilization of median nerve with task based activities .Neural mobilization technique will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 week.
while task based activities will be performed with the dosage of 45 minutes session 5 days weekly for 6 weeks and 17 participants will be assigned to control group (B
)which will undergo only neural mobilization of median nerve and will receive neural mobilization with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 weeks. After applying both interventions motor function improvement and spasticity reduction will be measured by using BBT, wolf motor scale and fugl -Meyer assessment scale and data will be analyzed through sPss Version 25.
- Conditions
- Chronic Stroke
- Being tested
- Neural mobilization, Task based activities
- Keywords
- Neural mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilizationOther
Also called Task based activities
Neural mobilization will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval of rest between each set for 4 days weekly for six week
Task based activitiesOther
Task based activities consisted of different types task which will be performed with the dosage of 45 minute session 5 days weekly for six week.
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization | Experimental | Neural mobilization technique will be perormed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for Six week. Receives: Other: Neural mobilization |
| Task based activities | Experimental | Task based activities consisted of different type of task which will be performed with the doasage of 45 minutes per session 5 days weekly for 6 weeks. Receives: Other: Task based activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and block test
It measures unilateral gross manual dexterity
Measured: 6 weeks
Wolf motor Function Test
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks
Measured: 6 weeks
Fugl -Meyer assessment scale
It measure motor ability of upper extremity
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 posted14 Nov 2023
- Study start17 Jul 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion22 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Memona Ayesha, Ms-NMPT, Principal investigator, Ripha international university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131827
- Sponsor's protocol ID
- REC/RCR &/23/0233
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2023
- Last updated
- 29 Dec 2023
- 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Neural Mobilization With Task Based Activities on Spasticity and Motor Function of Upper Limb in Patients With Chronic Stroke.
- ClinicalTrials.gov ID
- NCT06131827
- Acronym / sponsor ID
- REC/RCR &/23/0233
- Conditions
- Chronic Stroke
- Keywords
- Neural mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 22 Jan 2024 (estimated)
- First posted
- 14 Nov 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.
Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. In this study we use two techniques to improve upper limb motor dysfunction and reduce spasticity. One is task-based activities which is used to improve motor function and focus on active participation rather than normal movement pattern and other is neural mobilization which aims to reduce spasticity which is most common in stroke patients.
Detailed description
This study will be randomized controlled trial. Participants having stroke past 6 month to 1 year and mini mental state examination score >21 will be included in this study. And participants with severe orthopedic deformity, joint pain and visual impairment will be excluded from this study. The sample size will consist of 34 participants selected through non probability convenient sampling technique, which will further be randomized through sealed envelope method and will divide into two groups .Data will be collected using assessment tools, including the Fugl Mayer assessment scale, box and block test and wolf motor function test. 17 Participants will be assigned to the interventional group (A )which will undergo neural mobilization of median nerve with task based activities .Neural mobilization technique will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 week.
while task based activities will be performed with the dosage of 45 minutes session 5 days weekly for 6 weeks and 17 participants will be assigned to control group (B
)which will undergo only neural mobilization of median nerve and will receive neural mobilization with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for 6 weeks. After applying both interventions motor function improvement and spasticity reduction will be measured by using BBT, wolf motor scale and fugl -Meyer assessment scale and data will be analyzed through sPss Version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization | Experimental | Other: Neural mobilizationNeural mobilization technique will be perormed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval for rest between each set for 4 days weekly for Six week. |
| Task based activities | Experimental | Other: Task based activitiesTask based activities consisted of different type of task which will be performed with the doasage of 45 minutes per session 5 days weekly for 6 weeks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female stroke patients.
- 6 month to one year post stroke .
- Age 30-55
- Stable patients
- Mini - mental state examination>2
Key exclusion criteria (4 listed)
- Orthopedic deformity
- Patients undergo bottulinuminjection toxin injection
- Visual impairments
- Joint pain (elbow, shoulder, wrist)
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 |
|---|---|---|
| Neural mobilizationAlso: Task based activitiesNeural mobilization will be performed with twenty oscillations per minute being repeated three sets of one minute respecting one minute interval of rest between each set for 4 days weekly for six week | Other | Neural mobilization |
| Task based activitiesTask based activities consisted of different types task which will be performed with the dosage of 45 minute session 5 days weekly for six week. | Other | Task based activities |
Primary outcome
Box and block test
Time frame: 6 weeks
It measures unilateral gross manual dexterity
Wolf motor Function Test
Time frame: 6 weeks
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks
Fugl -Meyer assessment scale
Time frame: 6 weeks
It measure motor ability of upper extremity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Lumbar Spinal Manipulation in Stroke
Stroke
Recruiting
Effect of Lower Limb Proprioceptive Neuromuscular Facilitation Combined With Core Stability Training Versus Proprioceptive Neuromuscular Facilitation Alone on Balance and Functional Mobility in Chronic Stroke Survivors
Stroke
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Recruiting
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
Chronic Stroke
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.
Memona Ayesha, Ms-NMPT principal investigator
Ripha international university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization and Task based activities in people with Chronic Stroke, run by Riphah International 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 6 inclusion and 4 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 29 Dec 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 Memona Ayesha (03129601249, memonaayesha66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and block test (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 29 Dec 2023.