Back to resultsEffect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Myofascial release technique along with conventional physiotherapy exercises
Conventional physiotherapy exercises
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Myofascial release, Chronic stroke, Motor functions, Spasticity, modified Ashworth scale, Fugl-Meyer assessment scale
Eligibility Criteria
Inclusion Criteria:
- Unilateral stroke,
- Hemiplegia with upper extremity dysfunctions of more than 6 months and less than 2 years of duration
- modified Ashworth scale of grade 1-3,
- Mini-Mental State Exam (MMSE) >24 suggesting intact cognition,
- full passive range of motion of the shoulder, elbow, wrist, and hand joints
- voluntary control by Brunnstrom of grade 3-5 for shoulder, elbow, and wrist joints
Exclusion Criteria:
- circulatory problems such as deep vein thrombosis,
- impaired sensation over the affected upper limb,
- recently injured area/open wounds,
- arthritic or any other musculoskeletal condition of the upper extremity, shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test,
- history of brain surgery after stroke,
- Botox injection in the past four months,
- medically unstable patients,
- patients who have had multiple strokes.
Sites / Locations
- King Saud University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Myofascial Release Group
Conventional Physiotherapy Group
Arm Description
Participants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball.
A conventional physiotherapy program was provided including range of motion/flexibility exercises, strength training, postural control, functional mobility exercises, lower limb functional exercises, and gait training.
Outcomes
Primary Outcome Measures
Spasticity
Spasticity measured using Modified Ashworth scale - Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Upper limb motor functions
Upper limb motor functions measured using Fugl-Meyer Assessment Scale - Scores range from 0-66, where lower score represent poor performance of upper extremity and higher scores represents good performance of upper extremity
Secondary Outcome Measures
Full Information
NCT ID
NCT05242679
First Posted
February 6, 2022
Last Updated
February 16, 2022
Sponsor
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT05242679
Brief Title
Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
Official Title
Effect of Myofascial Release With Tennis Ball on Spasticity and Upper Limb Motor Functions in Patients With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
August 8, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Impaired motor function and upper extremity spasticity are common concerns in patients after stroke. It is essential to plan therapeutic techniques to recover from the stroke. The objective of this study was to investigate the effects of myofascial release with the tennis ball on spasticity and motor functions of the upper extremity in patients with chronic stroke.
Detailed Description
Myofascial release is a therapeutic technique that aims to improve flexibility and sliding between layers of soft tissues, reduce the severity of muscle activity pain, and improve functional performance. A previous study included myofascial release with a tennis ball in the lower extremity in patients with chronic stroke and reported improved balance. Different other unique therapeutic interventions have been proposed over the past two decades for stroke management; however, myofascial release with a tennis ball has not been included in them. Therefore, the present study aimed to examine the effects of myofascial release with a tennis ball on spasticity and motor functions of the upper limb in patients with chronic stroke.
Participants were equally divided into two groups viz. experimental and control, with 11 participants in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Myofascial release, Chronic stroke, Motor functions, Spasticity, modified Ashworth scale, Fugl-Meyer assessment scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel pre-test-post-test experimental design.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myofascial Release Group
Arm Type
Experimental
Arm Description
Participants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball.
Arm Title
Conventional Physiotherapy Group
Arm Type
Active Comparator
Arm Description
A conventional physiotherapy program was provided including range of motion/flexibility exercises, strength training, postural control, functional mobility exercises, lower limb functional exercises, and gait training.
Intervention Type
Other
Intervention Name(s)
Myofascial release technique along with conventional physiotherapy exercises
Intervention Description
Myofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy exercises
Intervention Description
Conventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training.
Primary Outcome Measure Information:
Title
Spasticity
Description
Spasticity measured using Modified Ashworth scale - Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Time Frame
4 weeks.
Title
Upper limb motor functions
Description
Upper limb motor functions measured using Fugl-Meyer Assessment Scale - Scores range from 0-66, where lower score represent poor performance of upper extremity and higher scores represents good performance of upper extremity
Time Frame
4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral stroke,
Hemiplegia with upper extremity dysfunctions of more than 6 months and less than 2 years of duration
modified Ashworth scale of grade 1-3,
Mini-Mental State Exam (MMSE) >24 suggesting intact cognition,
full passive range of motion of the shoulder, elbow, wrist, and hand joints
voluntary control by Brunnstrom of grade 3-5 for shoulder, elbow, and wrist joints
Exclusion Criteria:
circulatory problems such as deep vein thrombosis,
impaired sensation over the affected upper limb,
recently injured area/open wounds,
arthritic or any other musculoskeletal condition of the upper extremity, shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test,
history of brain surgery after stroke,
Botox injection in the past four months,
medically unstable patients,
patients who have had multiple strokes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masood Khan, M.P.Th
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35945719
Citation
Parikh RJ, Sutaria JM, Ahsan M, Nuhmani S, Alghadir AH, Khan M. Effects of myofascial release with tennis ball on spasticity and motor functions of upper limb in patients with chronic stroke: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 5;101(31):e29926. doi: 10.1097/MD.0000000000029926.
Results Reference
derived
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Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
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