Neural Mobilization for Reduction of Spasticity in Stroke

Sponsor
Asir John Samuel (Other)
Overall Status
Completed
CT.gov ID
NCT05314465
Collaborator
(none)
7
3
1
3.7
2.3
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Median nerve mobilization
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke
Actual Study Start Date :
Nov 22, 2021
Actual Primary Completion Date :
Feb 19, 2022
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

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

Other: Median nerve mobilization
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

Primary Outcome Measures

  1. Modified Ashworth Scale (MAS) [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.

Secondary Outcome Measures

  1. Brunnstrom's stages for hand recovery [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.

  2. Hydraulic hand dynamometer [Change from baseline and 4 weeks]

    For grip and pinch strength

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation Ambala Haryana India 133207
2 Healing Hands Physiotherapy & Rehabilitation Hisar Haryana India 125001
3 Bedi Hospital Kaithal Haryana India 136027

Sponsors and Collaborators

  • Asir John Samuel

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asir John Samuel, Professor, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier:
NCT05314465
Other Study ID Numbers:
  • MMDU/IEC/1935
  • U1111-1276-6515
First Posted:
Apr 6, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Asir John Samuel, Professor, Maharishi Markendeswar University (Deemed to be University)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022