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Completed

NCT Number: NCT07350096

The Effects of Intensive Physiotherapy 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).

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. The Selective Motor Control of the Upper Extremity

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

    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.

  3. The Selective Motor Control of the Lower Extremity

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

    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.

Secondary outcomes

  1. Gross Motor Function Measure-88 (GMFM-88)

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

    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,

    • - Initiates the movement (<10% of the task),
    • - Partially completes the movement (10-90% of the task),
    • - Completes the movement independently. Scores for each dimension are calculated as percentages. The total GMFM-88 score is obtained by averaging the five dimension percentage scores (0-100). Higher percentage scores indicate better gross motor function.
  2. Modified Ashworth Scale (MAS)

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

    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.

  3. Pediatric Quality of Life Inventory (PedsQL)

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

    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

    • ("Almost Never") = 75
    • ("Sometimes") = 50
    • ("Often") = 25
    • ("Almost Always") = 0 Scale scores are calculated as the mean of the completed item scores. To account for missing data, a scale score is computed only if at least 50% of the items are completed. If more than 50% of items are missing, the scale score is not calculated.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effects of Intensive Physiotherapy on Postural Control and Selective Motor Control of the Upper and Lower Extremities in Children With Spastic Cerebral Palsy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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