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Neural Mobilization for Reduction of Spasticity in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Median nerve mobilization
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, spasticity, neural mobilization, Upper limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants with subacute and chronic stroke (1month and above) having upper limb spasticity.
  2. Participants with haemorrhagic and ischemic stroke.
  3. Participants who tolerate the supine position.
  4. Participants who are oriented and alert.
  5. Both males and females.
  6. Participants older than 18 years.

Exclusion Criteria:

  1. Participants with a score greater than 3 on The Modified Ashworth Scale.
  2. Participants with affected speech.
  3. Participants with upper limb deformity.
  4. Participants experiencing dizziness.
  5. Any increase in the dosage of anti-spastic medications during the intervention period.
  6. General health problems or pathologies that affect the nervous system like uncontrolled diabetes, hypertension and recent surgeries.
  7. Recent onset of worsening neurological signs.

Sites / Locations

  • Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation
  • Healing Hands Physiotherapy & Rehabilitation
  • Bedi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Median nerve mobilization

Arm Description

Experimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks

Outcomes

Primary Outcome Measures

Modified Ashworth Scale (MAS)
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.

Secondary Outcome Measures

Brunnstrom's stages for hand recovery
To check recovery of hand functions. Total 7 grades are there. Increase in grade means increase in hand functions.
Hydraulic hand dynamometer
For grip and pinch strength

Full Information

First Posted
March 30, 2022
Last Updated
August 16, 2022
Sponsor
Asir John Samuel
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1. Study Identification

Unique Protocol Identification Number
NCT05314465
Brief Title
Neural Mobilization for Reduction of Spasticity in Stroke
Official Title
Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, spasticity, neural mobilization, Upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Median nerve mobilization
Arm Type
Experimental
Arm Description
Experimental arm given Median nerve mobilization for 12mins 3sets for 3mins each with 1 minute interval in between for 5times a week for 4weeks
Intervention Type
Other
Intervention Name(s)
Median nerve mobilization
Intervention Description
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 Information:
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
Change from baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Brunnstrom's stages for hand recovery
Description
To check recovery of hand functions. Total 7 grades are there. Increase in grade means increase in hand functions.
Time Frame
Change from baseline and 4 weeks
Title
Hydraulic hand dynamometer
Description
For grip and pinch strength
Time Frame
Change from baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rittu Sharma, (MPT)
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asir John Samuel, Ph.D
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Akanksha Saxena, (Ph.D)
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India
Facility Name
Healing Hands Physiotherapy & Rehabilitation
City
Hisar
State/Province
Haryana
ZIP/Postal Code
125001
Country
India
Facility Name
Bedi Hospital
City
Kaithal
State/Province
Haryana
ZIP/Postal Code
136027
Country
India

12. IPD Sharing Statement

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Neural Mobilization for Reduction of Spasticity in Stroke

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