- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05314465
Neural Mobilization for Reduction of Spasticity in Stroke
August 16, 2022 updated by: Asir John Samuel
Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult.
There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength.
This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke.
This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated).
Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks.
Outcome measures were Modified Ashworth Scale (MAS), Brunnstrom's grading of hand recovery and Hydraulic hand dynamometer(HHD) for grip and pinch strength.
Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
Study Overview
Detailed Description
Spasticity after stroke is common that affect upper limb strength and make activities of daily living difficult.
There are many techniques but not any standardized technique for long term effect on reduction of spasticity and improving upper limb strength.
This study aimed to explore and understand the effectiveness of neural mobilization on reduction of spasticity and improving upper limb strength in individuals with stroke.
This is mixed method approach of embedded design, multicentric study recruited 7 individuals with stroke as no new themes or codes were emerging (data saturated).
Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks.
Primary outcome measure was Modified Ashworth Scale (MAS) to assess elbow and wrist flexors spasticity and secondary outcome measures were Brunnstrom's stages for hand recovery and Hydraulic hand dynamometer(HHD) to measure grip and pinch strength.
Pre and post outcomes data were collected at baseline and 4weeks after intervention and in depth face to face structured interviews was conducted after 4weeks of intervention to explore the effectiveness of median nerve mobilization on reduction of spasticity and the improvement of upper limb strength.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Ambala, Haryana, India, 133207
- Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation
-
Hisar, Haryana, India, 125001
- Healing Hands Physiotherapy & Rehabilitation
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Kaithal, Haryana, India, 136027
- Bedi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with subacute and chronic stroke (1month and above) having upper limb spasticity.
- Participants with haemorrhagic and ischemic stroke.
- Participants who tolerate the supine position.
- Participants who are oriented and alert.
- Both males and females.
- Participants older than 18 years.
Exclusion Criteria:
- Participants with a score greater than 3 on The Modified Ashworth Scale.
- Participants with affected speech.
- Participants with upper limb deformity.
- Participants experiencing dizziness.
- Any increase in the dosage of anti-spastic medications during the intervention period.
- General health problems or pathologies that affect the nervous system like uncontrolled diabetes, hypertension and recent surgeries.
- Recent onset of worsening neurological signs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Median nerve mobilization
Experimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks
|
Median nerve mobilization was given 20 oscillations per minute for 3 times & repeated 3 times with a pause of 1 minute between each sets for 5times/week for 4weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale (MAS)
Time Frame: Change from baseline and 4 weeks
|
For spasticity, Total 4 grades are there.
Grade 0 means no increase in muscle tone and grade 4 means affected part rigid in flexion or extension.
More grade means more spasticity is there.
|
Change from baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brunnstrom's stages for hand recovery
Time Frame: Change from baseline and 4 weeks
|
To check recovery of hand functions.
Total 7 grades are there.
Increase in grade means increase in hand functions.
|
Change from baseline and 4 weeks
|
Hydraulic hand dynamometer
Time Frame: Change from baseline and 4 weeks
|
For grip and pinch strength
|
Change from baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rittu Sharma, (MPT), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
- Study Chair: Asir John Samuel, Ph.D, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
- Study Director: Akanksha Saxena, (Ph.D), Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2021
Primary Completion (Actual)
February 19, 2022
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMDU/IEC/1935
- U1111-1276-6515 (Other Identifier: WHO (UTN))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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