The Effects of Intensive Physiotherapy in Children With Spastic Cerebral Palsy

Medipol University

Status: Completed

Conditions: Cerebral Palsy (CP)

Treatments: Behavioral: Neurodevelopmental Therapy; Behavioral: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07350096

10840098-604.01.01-E.5016

Details and patient eligibility

About

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).

Full description

This study was not prospectively registered in a public trials registry. Registration was completed retrospectively after data collection had been completed.

Enrollment: 30 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intensive Physiotherapy Program

Experimental group

Description:

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

Treatment:

Behavioral: Neurodevelopmental Therapy

Conventional Physiotherapy Program

Experimental group

Description:

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

Treatment:

Behavioral: Conventional Therapy