NCT05242679

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

February 6, 2022

Last Update Submit

February 16, 2022

Conditions

Keywords

Myofascial releaseChronic strokeMotor functionsSpasticitymodified Ashworth scaleFugl-Meyer assessment scale

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 weeks.

  • 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

    4 weeks.

Study Arms (2)

Myofascial Release Group

EXPERIMENTAL

Participants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball.

Other: Myofascial release technique along with conventional physiotherapy exercises

Conventional Physiotherapy Group

ACTIVE COMPARATOR

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.

Other: Conventional physiotherapy exercises

Interventions

Myofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises.

Myofascial Release Group

Conventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training.

Conventional Physiotherapy Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

Related Publications (1)

  • 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.

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

  • Masood Khan, M.P.Th

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel pre-test-post-test experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2022

First Posted

February 16, 2022

Study Start

November 21, 2016

Primary Completion

August 8, 2017

Study Completion

October 23, 2017

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations