Stroke (Subacute)NCT07537322
Effect of DFM on Quadriceps Spasticity in Stroke Patients
A study testing Deep Friction Massage and Physical Therapy Exercise only in people with Stroke (Subacute), run by Majmaah University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke (Subacute)
- What is being tested?
- Deep Friction Massage and Physical Therapy Exercise only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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)
- Being tested
- Deep Friction Massage, Physical Therapy Exercise only
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Friction MassageOther
DFM Placed over-the-quadriceps muscle fibers to reduce the spasticity
Physical Therapy Exercise onlyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Deep Friction Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Assessment 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline Assessment 6 weeks
Knee Joint Range of Motion (ROM).
Flexion and extension range measured with a universal goniometer.
Measured: Baseline Assessment 6 weeks
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.
Measured: Baseline Assessment 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke (Subacute)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be into 2 equal groups: * Intervention group: Deep friction massage and physiotherapy. * Control group: Structured physiotherapy exclusively.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danah Mohammed Alyahya, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537322
- Sponsor's protocol ID
- Majmaah Uni.2025-138
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data that underlie the results reported in a publication will be shared upon reasonable request from the corresponding author
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.
PubMed 33919371
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Friction Massage on Quadriceps Spasticity in Patients With Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT07537322
- Acronym / sponsor ID
- Majmaah Uni.2025-138
- Conditions
- Stroke (Subacute)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants will be into 2 equal groups: * Intervention group: Deep friction massage and physiotherapy. * Control group: Structured physiotherapy exclusively.
| Arm | Type | Receives |
|---|---|---|
| PT Group | Sham comparator | Other: Physical Therapy Exercise onlyParticipants 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 |
| PT with DFM Group | Active comparator | Other: Deep Friction MassageThe 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Friction MassageDFM Placed over-the-quadriceps muscle fibers to reduce the spasticity | Other | PT with DFM Group |
| Physical Therapy Exercise onlyFormed 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 | Other | PT Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 33919371Cabanas-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.
- Individual participant dataSharing planned: No. Deidentified individual participant data that underlie the results reported in a publication will be shared upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Friction Massage and Physical Therapy Exercise only in people with Stroke (Subacute), run by Majmaah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danah M Alyahya, DSc of Physical Therapy (+966502224441, d.alyahya@mu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity of Quadriceps (by the Modified Ashworth Scale (MAS)) (time frame: Baseline Assessment 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07537322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.