AzTrials
AzTrials

Cerebral Palsy (CP)NCT07350096

The Effects of Intensive Physiotherapy in Children With Spastic Cerebral Palsy

A study testing Neurodevelopmental Therapy and Conventional Therapy in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 to 8 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Neurodevelopmental Therapy and Conventional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2020to 1 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University Department of Physiotherapy and Rehabilitation

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read more

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).

Read the detailed description

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

Being tested
Neurodevelopmental Therapy, Conventional Therapy
Keywords
cerebral palsy, intensive therapy, selective motor control, postural control, neurodevelopmental treatment
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurodevelopmental TherapyBehavioural

    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 TherapyBehavioural

    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

Study groups in NCT07350096
Study groupRoleWhat they receive
Intensive Physiotherapy ProgramExperimentalParticipants 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
Receives: Behavioral: Neurodevelopmental Therapy
Conventional Physiotherapy ProgramExperimentalParticipants 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
Receives: Behavioral: Conventional Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)
  1. Gross Motor Function Measure-88 (GMFM-88)

    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,

    1. - Initiates the movement (<10% of the task),
    2. - Partially completes the movement (10-90% of the task),
    3. - 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.

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

  2. Modified Ashworth Scale (MAS)

    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.

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

  3. Pediatric Quality of Life Inventory (PedsQL)

    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

    1. ("Almost Never") = 75
    2. ("Sometimes") = 50
    3. ("Often") = 25
    4. ("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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start15 Feb 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07350096
Sponsor's protocol ID
10840098-604.01.01-E.5016
Status last verified
Dec 2025
First submitted
28 Dec 2025
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 26837375
  • 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.

    PubMed 19220390
  • 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.

    PubMed 18834387
  • 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.

    PubMed 39354669
  • 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.

    PubMed 18402701
  • 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.

    PubMed 26526592
  • 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.

    PubMed 16700934
  • 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.

    PubMed 29152685
  • 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.

    PubMed 31900006
  • 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.

    PubMed 28272744
  • 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.

    PubMed 28378564
  • 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.

    PubMed 31311250
  • 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.

    PubMed 29673348
  • 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.

    PubMed 29383702
  • 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.

    PubMed 34994671

Questions about this trial

What is this clinical trial studying?

A study testing Neurodevelopmental Therapy and Conventional Therapy in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seated Postural Control Measure (time frame: Baseline (pre-intervention) and immediately after completion of the 2-week intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07350096, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in