Effect of Radial Shock Wave Therapy on Calf Muscle Tone, ROM, Gross Motor Scale, Plantar Surface and Quality of Life in Patients With Cerebral Palsy: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Hail
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- calf muscle tone
Study Overview
Brief Summary
the aim of this study to assess different outcome measures after applying standard physical therapy plus radial shockwave and compare the results with another group who received standard treatment only.
Design: double-blinded (assessor and data analyzer)
Methods: This study will be conducted in 4 rehabilitation facilities, Times for 1 month of intervention Assessment timeline: 3 times (T0: at baseline, T1: at 4 weeks, T2: follow up at 3 months. Outcome measures: the Modified Ashworth scale (MAS), Ankle ROM, Plantar surface area, Gross motor function, and quality of life
Detailed Description
the current study is a randomized controlled trial in which the researchers intended to examine the effect of adding radial shockwave therapy to standard physical therapy on the status of calf muscle spasticity and consequent effects on gross motor function, ankle joint ROM, plantar surface area, and quality of life.
the experimental intervention will consist of 4 sessions of radial shockwave applied to the bulkiest area of the calf muscle in children having spastic cerebral palsy. participants will receive 1 session of radial shockwave per week and will continue their regular physical therapy as usual (3 sessions per week).
outcome assessment will be conducted 3 times: at baseline, after the end of the treatment program, and at 3 months follow-up.
the tools that will be used to collect data will be:
- Modified Ashworth scale for muscle tone.
- Goniometer for Ankle ROM.
- EMed force platform for plantar surface area
- Gross motor function scale for gross motor function
- Cerebral Palsy Quality of Life Questionnaire for quality of life assessment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age between 8-14
- •diagnosed with spastic CP
- •ability to walk alone or with assistance
- •grades 1 -4 on Gross Motor Function Classification System
- •at least score 1 on the Modified Ashworth Scale (MAS)
- •ability to attend the treatment program and the outcome assessment sessions.
Exclusion Criteria
- •patients who received a botulinum toxin injection in the calf muscle during the last six months
- •structural contracture of the calf muscle
- •surgery in the lower extremity during the previous year
- •those experiencing pain in the lower limbs
- •severe associated neurological diseases as epilepsy
- •medications affecting peripheral muscle tone.
Arms & Interventions
Standard physical therapy program
all participants will receive strengthing, stretching, facilitation and inhibitory techniques, splinting, developmental techniques, gait, and balance training. The duration of each session will be 1 hour, 3 times per week for 4 weeks.
Intervention: Standard physical therapy program (Other)
Radial shockwave therapy (rSWT)
One session per week of rSWT will be applied using shockwave device. The following parameters will be used: Shocks number: 1500 per muscle, will be applied over the belly of the calf muscle using the 15 mm applicator head. The pressure will be 2 bar and the frequency will be 4 Hz. Patients will receive shock wave from prone position.
Intervention: Experimental Interventions (Other)
Outcomes
Primary Outcomes
calf muscle tone
Time Frame: at follow up (3months after the end of the treatment)
the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity
plantar surface area
Time Frame: at follow up (3months after the end of the treatment)
E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity
gross-motor function
Time Frame: at follow up (3months after the end of the treatment)
Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.
ankle joint ROM
Time Frame: at follow up (3months after the end of the treatment)
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
calf muscle tone
Time Frame: at baseline
the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity
calf muscle tone
Time Frame: at 4 weeks
the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity
ankle joint ROM
Time Frame: at baseline
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
ankle joint ROM
Time Frame: at 4 weeks
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
plantar surface area
Time Frame: at baseline
E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity
plantar surface area
Time Frame: at 4 weeks
E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity
gross-motor function
Time Frame: at baseline
Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.
gross-motor function
Time Frame: at 4 weeks
Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.
Secondary Outcomes
- cerebral palsy quality of life questionnaire(at follow up (3months after the end of the treatment))
- cerebral palsy quality of life questionnaire(at baseline)
- cerebral palsy quality of life questionnaire(at 4 weeks)
Investigators
Hisham Mohamed Hussein
principal investigator
University of Hail