Effect of DFM on Quadriceps Spasticity in Stroke Patients

NCT07537322 | Not Yet Recruiting

• 1 other identifier: Majmaah Uni.2025-138
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke (Subacute)

Outcome Measures

Primary Outcomes (1)

• Spasticity of Quadriceps (by the Modified Ashworth Scale (MAS))

  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 Outcomes (3)

• Fugl-Meyer Assessment

  Baseline Assessment 6 weeks

• Knee Joint Range of Motion (ROM).

  Baseline Assessment 6 weeks

• Timed Up and Go (TUG) test

  Baseline Assessment 6 weeks

Study Arms (2)

PT Group

SHAM COMPARATOR

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

PT with DFM Group

ACTIVE COMPARATOR

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

Interventions

Deep Friction Massage OTHER

DFM Placed over-the-quadriceps muscle fibers to reduce the spasticity

PT with DFM Group

Physical Therapy Exercise only OTHER

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

PT Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Majmaah University: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Danah M Alyahya, DSc of Physical Therapy

CONTACT

+966502224441; d.alyahya@mu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: participants will be into 2 equal groups: * Intervention group: Deep friction massage and physiotherapy. * Control group: Structured physiotherapy exclusively.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share