Effect of DFM on Quadriceps Spasticity in Stroke Patients

April 12, 2026 updated by: Danah Mohammed Alyahya, Majmaah University

Effect of Deep Friction Massage on Quadriceps Spasticity in Patients With Sub-acute Stroke

The goal of this clinical trial is to learn if deep friction massage works to reduce quadriceps muscle spasticity in adults with sub-acute Stroke. It will also learn about the effectiveness of this technique in improving lower limb motor function and mobility.

The main questions it aims to answer are:

  • Does deep friction massage reduce quadriceps spasticity in stroke patients as measured by the Modified Ashworth Scale?
  • Does deep friction massage improve lower limb motor recovery as measured by the Fugl-Meyer Assessment?
  • Does deep friction massage improve functional mobility as measured by the Timed Up and Go Test?

Researchers will compare deep friction massage combined with conventional physiotherapy to conventional physiotherapy alone to see if deep friction massage improves spasticity and functional outcomes in patients with stroke.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Danah M Alyahya, DSc of Physical Therapy
  • Phone Number: +966502224441
  • Email: d.alyahya@mu.edu.sa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 40 years
  • Ischemic or hemorrhagic stroke diagnosis.
  • Subacute stage (1-6 months after stroke)
  • Quadriceps spasticity (Modified Ashworth Scale 1 or above)
  • Walking with or without assistive aids.
  • Stable health-wise and can be involved in rehabilitation.

Exclusion Criteria:

  • The participants were not allowed in case they had:
  • Severe mental failure (MMSE score under 24)
  • Lower limb musculoskeletal or other neurological disorders.
  • Contraindications to massage therapy (e.g. thrombosis, skin infection, fracture)
  • Weakened or no spasticity of the quadriceps.
  • Extreme medical instability inability to take part.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: PT Group

Participants in this group will receive:

  • physiotherapy program without massage therapy.

  • The physiotherapy program will include the following 10 exercises:

    1. Passive quadriceps stretch
    2. Active-assisted heel slides
    3. Seated knee extensions
    4. Bridging exercise
    5. Straight leg raises
    6. Wall slides (mini-squats)
    7. Low platform step-up training
    8. Sit-to-stand practice
    9. Balance training (in place and on single leg)
    10. Parallel bar gait training
Other: Physical Therapy Exercise only

Formed Physiotherapy Program.

The participants will provided with a standardized therapeutic exercise program including:

  1. Quadriceps stretch positioning.
  2. Active-assisted heel slides
  3. Seated knee extensions
  4. Bridging exercises
  5. Straight leg raises
  6. Wall slides (mini-squats)
  7. The step-up low platform training.
  8. Sit-to-stand training
  9. Training on static and dynamic balance.
  10. Parallel bar gait training
Active Comparator: PT with DFM Group

The participants will receive Deep Friction Massage (DFM) Placed over-the-quadriceps muscle fibers with a standardized therapeutic exercise program including:

  1. Quadriceps stretch positioning.
  2. Active-assisted heel slides
  3. Seated knee extensions
  4. Bridging exercises
  5. Straight leg raises
  6. Wall slides (mini-squats)
  7. The step-up low platform training.
  8. Sit-to-stand training
  9. Training on static and dynamic balance.
  10. Parallel bar gait training also provided with a standardized therapeutic exercise program including:

1. Quadriceps stretch positioning. 2. Active-assisted heel slides 3. Seated knee extensions 4. Bridging exercises 5. Straight leg raises 6. Wall slides (mini-squats) 7. The step-up low platform training. 8. Sit-to-stand training 9. Training on static and dynamic balance. 10. Parallel bar gait training
Other: Deep Friction Massage
DFM Placed over-the-quadriceps muscle fibers to reduce the spasticity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity of Quadriceps (by the Modified Ashworth Scale (MAS))
Time Frame: Baseline Assessment 6 weeks
This is a scale used to assess resistance to passive muscle stretch with a scale of 0 to 4 with a 1+ category. Increased scores depict increased spasticity.
Baseline Assessment 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment
Time Frame: Baseline Assessment 6 weeks
Measured with the motor domain of Fugl-Meyer Assessment. This tests voluntary movement, reflex movement and coordination and the higher the scores of the movements, the better the motor performance.
Baseline Assessment 6 weeks
Knee Joint Range of Motion (ROM).
Time Frame: Baseline Assessment 6 weeks
Flexion and extension range measured with a universal goniometer.
Baseline Assessment 6 weeks
Timed Up and Go (TUG) test
Time Frame: Baseline Assessment 6 weeks
The Timed Up and Go (TUG) test was used to measure it, as it is a dynamic balance and functional mobility test.
Baseline Assessment 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Majmaah University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Cabanas-Valdés, R., J. Calvo-Sanz, et al. (2021). "The effectiveness of massage therapy for improving sequelae in post-stroke survivors. A systematic review and meta-analysis." International journal of environmental research and public health 18(9): 4424.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Majmaah Uni.2025-138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified individual participant data that underlie the results reported in a publication will be shared upon reasonable request from the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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