StrokeNCT05242679
Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
A study testing Myofascial release technique along with conventional physiotherapy exercises and Conventional physiotherapy exercises in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Myofascial release technique along with conventional physiotherapy exercises and Conventional physiotherapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Nov 2016to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myofascial Release With Tennis Ball on Spasticity and Upper Limb Motor Functions in Patients With Chronic Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Myofascial release technique along with conventional physiotherapy exercises, Conventional physiotherapy exercises
- Keywords
- Myofascial release, Chronic stroke, Motor functions, Spasticity, modified Ashworth scale, Fugl-Meyer assessment scale
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial release technique along with conventional physiotherapy exercisesOther
Myofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises.
Conventional physiotherapy exercisesOther
Conventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release Group | Experimental | Participants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball. Receives: 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. Receives: Other: Conventional physiotherapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start21 Nov 2016
- Primary completion8 Aug 2017
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel pre-test-post-test experimental design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242679
- Sponsor's protocol ID
- GSTIESC/23/16
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35945719
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release With Tennis Ball on Spasticity and Upper Limb Motor Functions in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05242679
- Acronym / sponsor ID
- GSTIESC/23/16
- Conditions
- Stroke
- Keywords
- Myofascial release, Chronic stroke, Motor functions, Spasticity, modified Ashworth scale, Fugl-Meyer assessment scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel pre-test-post-test experimental design.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Group | Experimental | Other: Myofascial release technique along with conventional physiotherapy exercisesParticipants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball. |
| Conventional Physiotherapy Group | Active comparator | Other: Conventional physiotherapy exercisesA 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial release technique along with conventional physiotherapy exercisesMyofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises. | Other | Myofascial Release Group |
| Conventional physiotherapy exercisesConventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training. | Other | Conventional Physiotherapy Group |
Primary outcome
Spasticity
Time frame: 4 weeks.
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
Time frame: 4 weeks.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 35945719Parikh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masood Khan, M.P.Th principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release technique along with conventional physiotherapy exercises and Conventional physiotherapy exercises in people with Stroke, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.