- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454655
The Effect of Percussion Massage Therapy in Stroke Patients
The Effect of Percussion Massage Therapy on Muscle Tone, Walking and Balance Functions in Chronic Stroke Patients
Stroke is an acute neurological condition resulting from cerebral ischemia or hemorrhage, frequently leading to impaired motor function, increased muscle tone, and deficits in balance and gait. Spasticity is a common long-term complication in individuals with chronic stroke and significantly affects functional mobility and quality of life.
Percussion Massage Therapy (PMT) is an emerging intervention that combines principles of mechanical vibration and traditional soft tissue techniques. Although previous research has examined its effects in musculoskeletal and athletic populations, evidence regarding its use in individuals with chronic stroke remains limited.
The aim of this study is to investigate the effects of percussion massage therapy on muscle tone in individuals with chronic stroke and to determine whether changes in muscle tone are associated with improvements in gait and balance performance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke frequently results in persistent neuromuscular impairments, including increased muscle tone, altered motor control, and reduced postural stability. Spasticity, particularly in the chronic phase, contributes to joint stiffness, abnormal movement patterns, and decreased functional independence. Interventions targeting muscle tone reduction may therefore support improvements in gait and balance.
Percussion Massage Therapy (PMT) is delivered handheld mechanical devices that apply rapid, repetitive pressure pulses to myofascial tissues. These mechanical stimuli are thought to promote muscle relaxation, enhance proprioceptive input, modulate pain perception, and facilitate local circulation. By inducing mechanical deformation within soft tissues, PMT may influence neuromuscular activation patterns and reduce hypertonicity.
While studies have reported beneficial effects of massage and vibration-based interventions on muscle stiffness and functional performance in various populations, data specifically addressing individuals with chronic stroke are scarce. In particular, the relationship between PMT-induced changes in spasticity and functional outcomes such as gait and balance has not been adequately explored.
This study is designed to evaluate the effects of PMT on muscle tone in individuals with chronic stroke and to examine whether potential reductions in spasticity translate into measurable improvements in gait and balance performance. The findings are expected to contribute to the evidence base for adjunctive rehabilitation strategies in chronic stroke management
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gaziantep
-
Gaziantep, Gaziantep, Turkey (Türkiye), 27090
- Sanko Unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having had a unilateral stroke and being in the chronic phase (≥6 months, ≤2 years).
- Age: 40-65 years old.
- Hemiplegic patients with lower limb dysfunction.
- Mini-Mental State Examination (MMSE) score ≥24. Lower limb spasticity of 1-3 on the Modified Ashworth Scale (MAS).
- Full passive range of motion (ROM) in the hip, knee, and ankle joints.
- Ability to stand independently for at least 1 minute.
Exclusion Criteria:
- Individuals with neurological, orthopaedic, metabolic, and rheumatological conditions that may affect soft tissues.
- Patients who have undergone spasticity treatment or other therapies within the last three months.
- Individuals with lower limb injuries.
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Percussion Massage Therapy (PMT)
|
Treatment for both groups will last for 6 weeks, 3 days a week, with each session lasting approximately 45-60 minutes. Assessment sessions will last 30-40 minutes and will be conducted independently of the treatment sessions. Assessment sessions will be conducted twice, before and after treatment. The Classical Physiotherapy Programme applied to both groups will consist of stretching exercises, strengthening exercises, walking and balance training, and neuromuscular electrical stimulation applied to the lower extremity muscles. Percussion Massage Therapy (PMT), which will be applied in addition to the experimental group, will be applied to the hip adductors, knee extensors, and ankle plantar flexors belonging to the lower extremity extensor synergy. Application Method: PMT will be applied to each muscle group of the lower extremity for 2-3 minutes. |
|
Experimental: Conventional Rehabilitation
|
Treatment for both groups will last for 6 weeks, 3 days a week, with each session lasting approximately 45-60 minutes. Assessment sessions will last 30-40 minutes and will be conducted independently of the treatment sessions. Assessment sessions will be conducted twice, before and after treatment. The Classical Physiotherapy Programme applied to both groups will consist of stretching exercises, strengthening exercises, walking and balance training, and neuromuscular electrical stimulation applied to the lower extremity muscles. Percussion Massage Therapy (PMT), which will be applied in addition to the experimental group, will be applied to the hip adductors, knee extensors, and ankle plantar flexors belonging to the lower extremity extensor synergy. Application Method: PMT will be applied to each muscle group of the lower extremity for 2-3 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10-Meter Walk Test:
Time Frame: 3 months
|
a standard clinical measurement tool that objectively assesses an individual's walking speed.
In the study area, the walking speed (m/s) is calculated by timing the middle 10 metres of a straight line.
|
3 months
|
|
Myoton® PRO
Time Frame: 3 months
|
measures muscle tone
|
3 months
|
|
Timed Up and Go Test (TUG);
Time Frame: 3 months
|
The Timed Up and Go Test (TUG) is a practical test that assesses functional mobility components such as rising from a seated position, walking a certain distance, turning around, and sitting back down.
|
3 months
|
|
Berg Balance Scale (BBS)
Time Frame: 3 months
|
The Berg Balance Scale is a clinical measure developed to assess static and dynamic balance and evaluate balance performance in activities of daily living.
In stroke rehabilitation, the BBS is widely used to quantitatively determine balance impairment and monitor balance changes.
It is one of the most frequently recommended balance assessment tools in stroke clinical practice guidelines worldwide and is associated with gait, fall risk, and postural control.
|
3 months
|
|
Digital goniometer
Time Frame: 3 months
|
Joint position sense and proprioception assessment will be performed using a digital goniometer for the hip, knee, and ankle joints.
During measurement, the participant will be placed in the appropriate starting position, and the rele
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hakanpolat14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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