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NCT Number: NCT07537322

Effect of DFM on Quadriceps Spasticity in Stroke Patients

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.

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Key information

Conditions

Stroke (Subacute) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep friction massage

Other

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

Physical Therapy Exercise only

Other

Formed Physiotherapy Program.

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

  • Quadriceps stretch positioning.
  • Active-assisted heel slides
  • Seated knee extensions
  • Bridging exercises
  • Straight leg raises
  • Wall slides (mini-squats)
  • The step-up low platform training.
  • Sit-to-stand training
  • Training on static and dynamic balance.
  • Parallel bar gait training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Knee Joint Range of Motion (ROM).

    Time frame: Baseline Assessment 6 weeks

    Flexion and extension range measured with a universal goniometer.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danah M Alyahya, DSc of Physical Therapy

CONTACT

[email protected]

+966502224441

Sponsors and collaborators

Lead sponsor

Majmaah University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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