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Not yet recruiting NCT07537322

Effect of DFM on Quadriceps Spasticity in Stroke Patients

No phase Interventional Stroke (Subacute)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Friction Massage, Physical Therapy Exercise only.
Who it may be relevant to
Registry conditions: Stroke (Subacute). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Deep Friction Massage
    DFM Placed over-the-quadriceps muscle fibers to reduce the spasticity
  • 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

Primary outcome measures

  • Spasticity of Quadriceps (by the Modified Ashworth Scale (MAS)) [Time frame: Baseline Assessment 6 weeks]
Secondary outcome measures (3)
  • Fugl-Meyer Assessment [Time frame: Baseline Assessment 6 weeks]
  • Knee Joint Range of Motion (ROM). [Time frame: Baseline Assessment 6 weeks]
  • Timed Up and Go (TUG) test [Time frame: Baseline Assessment 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Cabanas-Valdes R, Calvo-Sanz J, Serra-Llobet P, Alcoba-Kait J, Gonzalez-Rueda V, Rodriguez-Rubio PR. The Effectiveness of Massage Therapy for Improving Sequelae in Post-Stroke Survivors. A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Apr 21;18(9):4424. doi: 10.3390/ijerph18094424. PMID 33919371

Identifiers

NCT: NCT07537322 · Majmaah Uni.2025-138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗