Clinical trial NCT05314465: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke, spasticity, neural mobilization, Upper limb
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from baseline and 4 weeks
Secondary outcomes:
measure: Brunnstrom's stages for hand recovery
timeFrame: Change from baseline and 4 weeks
measure: Hydraulic hand dynamometer
timeFrame: Change from baseline and 4 weeks
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation
state: Haryana
city: Hisar
country: India
facility: Healing Hands Physiotherapy & Rehabilitation
state: Haryana
city: Kaithal
country: India
facility: Bedi Hospital
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Rittu Sharma, (MPT)
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Asir John Samuel, Ph.D
role: STUDY_CHAIR
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Akanksha Saxena, (Ph.D)
role: STUDY_DIRECTOR
References: