The Effects of Intensive Physiotherapy in Children With Spastic Cerebral Palsy

NCT07350096 | Completed

• 1 other identifier: 10840098-604.01.01-E.5016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; intensive therapy; selective motor control; postural control; neurodevelopmental treatment

Outcome Measures

Primary Outcomes (3)

• Seated Postural Control Measure

  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.

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

• The Selective Motor Control of the Upper Extremity

  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.

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

• The Selective Motor Control of the Lower Extremity

  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.

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

Secondary Outcomes (3)

• Gross Motor Function Measure-88 (GMFM-88)

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

• Modified Ashworth Scale (MAS)

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

• Pediatric Quality of Life Inventory (PedsQL)

  Baseline (pre-intervention) and immediately after completion of the 2-week intervention.

Study Arms (2)

Intensive Physiotherapy Program

EXPERIMENTAL

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: * Weight-shifting and reaching activities in crawling, sitting, kneeling, and standing positions * Functional and symmetrical reaching tasks in different postures * Actively assisted transitions between postures * Balance training and facilitation of protective reactions in various positions * Core stabilization exercises * Isolated strengthening exercises for upper and lower extremities * Proprioceptive training exercises

Behavioral: Neurodevelopmental Therapy

Conventional Physiotherapy Program

EXPERIMENTAL

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: * Stretching and strengthening exercises * Passive and active range of motion exercises * Balance and coordination exercises in different positions * Electrotherapy applications

Behavioral: Conventional Therapy

Interventions

Neurodevelopmental Therapy BEHAVIORAL

Intervention components included: * Weight-shifting and reaching activities in crawling, sitting, kneeling, and standing positions * Functional and symmetrical reaching tasks in different postures * Actively assisted transitions between postures * Balance training and facilitation of protective reactions in various positions * Core stabilization exercises * Isolated strengthening exercises for upper and lower extremities * Proprioceptive training exercises Frequency: 6 days per week Sessions: 2 sessions per day Session duration: 50 minutes Total sessions: 24

Intensive Physiotherapy Program

Conventional Therapy BEHAVIORAL

Intervention components included: * Stretching and strengthening exercises * Passive and active range of motion exercises * Balance and coordination exercises in different positions * Electrotherapy applications Frequency: 3 days per week Sessions: 1 session per day Session duration: 45 minutes Total sessions: 6

Conventional Physiotherapy Program

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

Related Publications (15)

• Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.

  PMID: 26837375 RESULT

• 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.

  PMID: 19220390 RESULT

• 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.

  PMID: 18834387 RESULT

• 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.

  PMID: 39354669 RESULT

• 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.

  PMID: 18402701 RESULT

• 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.

  PMID: 26526592 RESULT

• 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.

  PMID: 16700934 RESULT

• 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.

  PMID: 29152685 RESULT

• 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.

  PMID: 31900006 RESULT

• 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.

  PMID: 28272744 RESULT

• 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.

  PMID: 28378564 RESULT

• 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.

  PMID: 31311250 RESULT

• 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.

  PMID: 29673348 RESULT

• 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.

  PMID: 29383702 RESULT

• 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.

  PMID: 34994671 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Physiotherapist, MSc. Physiotherapist, Principal Investigator

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 20, 2026
• Study Start: February 15, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

TU (1)