Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05883020
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2023-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy
Sponsor:
University of Hail
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
1. Modified Ashworth scale for muscle tone.
2. Goniometer for Ankle ROM.
3. EMed force platform for plantar surface area
4. Gross motor function scale for gross motor function
5. Cerebral Palsy Quality of Life Questionnaire for quality of life assessment
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:
1. Modified Ashworth scale for muscle tone.
2. Goniometer for Ankle ROM.
3. EMed force platform for plantar surface area
4. Gross motor function scale for gross motor function
5. Cerebral Palsy Quality of Life Questionnaire for quality of life assessment
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: