Neural Mobilization for Reduction of Spasticity in Stroke

Stroke Clinical Trial

Official title:

Effectiveness of Neural Mobilization on Spasticity and Upper Limb Function in Individuals With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314465
• Other study ID #: MMDU/IEC/1935
• Secondary ID: U1111-1276-6515
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: August 2022
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 15, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

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.

Locations

Country	Name	City	State
India	Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation	Ambala	Haryana
India	Healing Hands Physiotherapy & Rehabilitation	Hisar	Haryana
India	Bedi Hospital	Kaithal	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline and 4 weeks
Secondary	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.	Change from baseline and 4 weeks
Secondary	Hydraulic hand dynamometer	For grip and pinch strength	Change from baseline and 4 weeks