## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** GSTIESC/23/16
#### Organization
**Class:** OTHER
**Full Name:** King Saud University
### Status Module
#### Completion Date
**Date:** 2017-10-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-04

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-08-08

**Type:** ACTUAL

#### Start Date
**Date:** 2016-11-21

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2022-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-06
**Study First Submit QC Date:** 2022-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** King Saud University

#### Responsible Party

**Investigator Affiliation:** King Saud University

**Investigator Full Name:** Masood Khan

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- Myofascial release

- Chronic stroke

- Motor functions

- Spasticity

- modified Ashworth scale

- Fugl-Meyer assessment scale

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Two-arm parallel pre-test-post-test experimental design.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Myofascial release technique along with conventional physiotherapy exercises

**Label:** Myofascial Release Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**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 Names:**

- Other: Conventional physiotherapy exercises

**Label:** Conventional Physiotherapy Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Myofascial Release Group

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

**Name:** Myofascial release technique along with conventional physiotherapy exercises

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Conventional Physiotherapy Group

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

**Name:** Conventional physiotherapy exercises

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Spasticity

**Time Frame:** 4 weeks.

**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

**Measure:** Upper limb motor functions

**Time Frame:** 4 weeks.

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** King Saud University

**Zip:** 11433

#### Overall Officials

**Official 1:**

**Affiliation:** King Saud University

**Name:** Masood Khan, M.P.Th

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 35945719

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009122

- Term: Muscle Hypertonia

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M12085

- Name: Muscle Spasticity

- Relevance: HIGH

- As Found: Spasticity

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12079

- Name: Muscle Hypertonia

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009128

- Term: Muscle Spasticity

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24
