Effect of DFM on Quadriceps Spasticity in Stroke Patients
ConditionStroke (Subacute)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMajmaah University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years
Ischemic or hemorrhagic stroke diagnosis.
Subacute stage (1-6 months after stroke)
Quadriceps spasticity (Modified Ashworth Scale 1 or above)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Deep Friction Massage
Other interventionDFM Placed over-the-quadriceps muscle fibers to reduce the spasticity
Physical Therapy Exercise only
Other interventionFormed 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
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: PT GroupSham comparator 1 intervention
Group B: PT with DFM GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline Assessment 6 weeksSecondary outcomes
1
Fugl-Meyer Assessment
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.
Time frame
Baseline Assessment 6 weeks2
Knee Joint Range of Motion (ROM).
Flexion and extension range measured with a universal goniometer.
Time frame
Baseline Assessment 6 weeks3
Timed Up and Go (TUG) test
The Timed Up and Go (TUG) test was used to measure it, as it is a dynamic balance and functional mobility test.
Time frame
Baseline Assessment 6 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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