NCT05314465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

March 30, 2022

Last Update Submit

August 16, 2022

Conditions

Keywords

Stroke, spasticity, neural mobilization, Upper limb

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Brunnstrom's stages for hand recovery

    Change from baseline and 4 weeks

  • Hydraulic hand dynamometer

    Change from baseline and 4 weeks

Study Arms (1)

Median nerve mobilization

EXPERIMENTAL

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

Interventions

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.

Median nerve mobilization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation

Ambāla, Haryana, 133207, India

Location

Healing Hands Physiotherapy & Rehabilitation

Hisar, Haryana, 125001, India

Location

Bedi Hospital

Kaithal, Haryana, 136027, India

Location

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rittu Sharma, (MPT)

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Asir John Samuel, Ph.D

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Akanksha Saxena, (Ph.D)

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 6, 2022

Study Start

November 22, 2021

Primary Completion

February 19, 2022

Study Completion

March 15, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations