- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350096
The Effects of Intensive Physiotherapy in Children With Spastic Cerebral Palsy
The Effects of Intensive Physiotherapy on Postural Control and Selective Motor Control of the Upper and Lower Extremities in Children With Spastic Cerebral Palsy
The aim of this study is to investigate the effects of a 2-week Neurodevelopmental Treatment (NDT)-based intensive physiotherapy program with active participation on postural control and selective motor control of the lower and upper extremities in children diagnosed with spastic cerebral palsy.
Thirty children with spastic type cerebral palsy, aged between 4 and 8 years, and classified as level II, III, or IV according to the Gross Motor Function Classification System (GMFCS), will be included in the study. Participants will be randomized into two groups.
The experimental group will receive an NDT-based intensive physiotherapy program with active participation for 2 weeks, 6 days per week, 2 sessions per day, with each session lasting 50 minutes. The control group will receive a conventional physiotherapy program for 2 weeks, 3 days per week, once per day, with each session lasting 45 minutes.
Outcome measures will be assessed before and after the intervention period and will include the Seated Postural Control Measure-Function (SPCM-Function), Selective Control Assessment of the Lower Extremity (SCALE), Selective Control of the Upper Extremity Scale (SCUES), Modified Ashworth Scale (MAS), Gross Motor Function Measure-88 (GMFM-88) and the Pediatric Quality of Life Inventory (PedsQL).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul Medipol University Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4-8 years,
- No Botulinum Toxin type A injections within the last 6 months,
- No orthopedic surgical intervention within the last 12 months,
- Able to understand simple verbal commands and cooperate,
- Diagnosed with cerebral palsy,
- Spastic clinical type,
- Classified as Gross Motor Function Classification System (GMFCS) levels II, III, and IV.
Exclusion Criteria:
- Failure to participate regularly in the treatment program,
- Failure to participate in pre- and post-treatment assessments,
- Children who were severely distressed, crying excessively, or uncooperative.
- Children who have cognitive problems,
- Children who have active seizures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive Physiotherapy Program
Participants in the experimental group received a 2-week intensive physiotherapy program based on Neurodevelopmental Treatment (NDT) principles with active participation. Frequency: 6 days per week Sessions: 2 sessions per day Session duration: 50 minutes Total sessions: 24 Intervention components included:
|
Intervention components included:
Frequency: 6 days per week Sessions: 2 sessions per day Session duration: 50 minutes Total sessions: 24 |
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Experimental: Conventional Physiotherapy Program
Participants in the control group received a 2-week conventional physiotherapy program. Frequency: 3 days per week Sessions: 1 session per day Session duration: 45 minutes Total sessions: 6 Intervention components included:
|
Intervention components included:
Frequency: 3 days per week Sessions: 1 session per day Session duration: 45 minutes Total sessions: 6 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seated Postural Control Measure
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
|
Seated Postural Control Measure (SPCM) evaluates static, active, and reactive trunk control at different trunk segments in a supported sitting position.
It identifies the highest trunk level at which independent postural control is achieved in children with cerebral palsy.
SPCM consists of three sub scales.
In this study only function subscale will be used.
The Function subscale of the Seated Postural Control Measure consists of 12 items evaluating head and trunk control during sitting, reaching, grasping and releasing, bimanual use, and wheelchair mobility.
Each item is scored on a 4-point ordinal scale ranging from 1 to 4 points, with higher scores indicating better task performance.
The total score of the Function subscale ranges from a minimum of 12 points to a maximum of 48 points.
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Selective Motor Control of the Upper Extremity
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Selective Control of the Upper Extremity Scale (SCUES) selective voluntary motor control of the shoulder, elbow, forearm, wrist, and fingers during functional tasks in children with cerebral palsy.
Higher scores indicate better selective motor control of the upper extremities.Selective motor control (SMC) is graded for each joint using a four-point ordinal scale: 3 points indicate normal selective motor control, 2 points- mildly impaired SMC, 1 point-moderately impaired SMC, 0 points- absence of SMC.
For each upper extremity maximum point is 15.
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Selective Motor Control of the Lower Extremity
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Selective Control Assessment of the Lower Extremity (SCALE) evaluates the ability to perform isolated voluntary movements at the hip, knee, ankle, subtalar joint, and toes independently of mass synergistic patterns in children with cerebral palsy.Higher scores indicate better SMC of the lower extremities.2
points- normal SMC, 1point impaired SMC, and 0 points unable to perform.
For each lower extremity maximum point is 10.
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Gross Motor Function Measure-88 (GMFM-88) evaluates changes in gross motor function, including lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping in children with cerebral palsy. The Gross Motor Function Measure-88 consists of 88 items and is administered through observation of motor performance by a physiotherapist in children with cerebral palsy. Each item is scored on a 4-point ordinal scale as follows: 0 - Does not initiate the movement,
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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Modified Ashworth Scale (MAS)
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Modified Ashworth Scale (MAS) assesses muscle spasticity of the upper and lower extremities by measuring resistance during passive movement.
Muscle tone is assessed using the Modified Ashworth Scale, which grades resistance to passive movement on an ordinal scale ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates rigidity in flexion and extension of the affected part.
Higher scores indicating greater spasticity.
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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The Pediatric Quality of Life Inventory assesses health-related quality of life in children with cerebral palsy through age-appropriate parent-report and child self-report forms.Items on the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales are reverse scored and linearly transformed to a 0-100 scale, where higher scores indicate better health-related quality of life. Item scoring is performed as follows: 0 ("Never") = 100
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Baseline (pre-intervention) and immediately after completion of the 2-week intervention.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.
- Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
- Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x.
- Choi JY. Motor Function Measurement in Children: Gross Motor Function Measure (GMFM). Ann Rehabil Med. 2024 Oct;48(5):301-304. doi: 10.5535/arm.240078. Epub 2024 Oct 2. No abstract available.
- Mutlu A, Livanelioglu A, Gunel MK. Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC Musculoskelet Disord. 2008 Apr 10;9:44. doi: 10.1186/1471-2474-9-44.
- Wagner LV, Davids JR, Hardin JW. Selective Control of the Upper Extremity Scale: validation of a clinical assessment tool for children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2016 Jun;58(6):612-7. doi: 10.1111/dmcn.12949. Epub 2015 Nov 3.
- Varni JW, Burwinkle TM, Berrin SJ, Sherman SA, Artavia K, Malcarne VL, Chambers HG. The PedsQL in pediatric cerebral palsy: reliability, validity, and sensitivity of the Generic Core Scales and Cerebral Palsy Module. Dev Med Child Neurol. 2006 Jun;48(6):442-9. doi: 10.1017/S001216220600096X.
- Gulati S, Sondhi V. Cerebral Palsy: An Overview. Indian J Pediatr. 2018 Nov;85(11):1006-1016. doi: 10.1007/s12098-017-2475-1. Epub 2017 Nov 20.
- Santamaria V, Rachwani J, Saussez G, Bleyenheuft Y, Dutkowsky J, Gordon AM, Woollacott MH. The Seated Postural & Reaching Control Test in Cerebral Palsy: A Validation Study. Phys Occup Ther Pediatr. 2020;40(4):441-469. doi: 10.1080/01942638.2019.1705456. Epub 2020 Jan 3.
- Balzer J, van der Linden ML, Mercer TH, van Hedel HJA. Selective voluntary motor control measures of the lower extremity in children with upper motor neuron lesions: a systematic review. Dev Med Child Neurol. 2017 Jul;59(7):699-705. doi: 10.1111/dmcn.13417. Epub 2017 Mar 8.
- Hong BY, Jo L, Kim JS, Lim SH, Bae JM. Factors Influencing the Gross Motor Outcome of Intensive Therapy in Children with Cerebral Palsy and Developmental Delay. J Korean Med Sci. 2017 May;32(5):873-879. doi: 10.3346/jkms.2017.32.5.873.
- Lee H, Kim EK, Son DB, Hwang Y, Kim JS, Lim SH, Sul B, Hong BY. The Role of Regular Physical Therapy on Spasticity in Children With Cerebral Palsy. Ann Rehabil Med. 2019 Jun;43(3):289-296. doi: 10.5535/arm.2019.43.3.289. Epub 2019 Jun 28.
- Park EY. Path analysis of strength, spasticity, gross motor function, and health-related quality of life in children with spastic cerebral palsy. Health Qual Life Outcomes. 2018 Apr 19;16(1):70. doi: 10.1186/s12955-018-0891-1.
- Sukal-Moulton T, Gaebler-Spira D, Krosschell KJ. The validity and reliability of the Test of Arm Selective Control for children with cerebral palsy: a prospective cross-sectional study. Dev Med Child Neurol. 2018 Apr;60(4):374-381. doi: 10.1111/dmcn.13671. Epub 2018 Jan 31.
- Tuncdemir M, Unes S, Karakaya J, Kerem Gunel M. Reliability and validity of the Turkish version of the Selective Control Assessment of the Lower Extremity (SCALE) in children with spastic cerebral palsy. Disabil Rehabil. 2023 Jan;45(1):106-110. doi: 10.1080/09638288.2021.2022783. Epub 2022 Jan 7.
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
- 10840098-604.01.01-E.5016
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
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