NCT07278154

Brief Summary

This study will recruit eligible participants from the Physical Therapy Department of the University of Lahore Teaching Hospital, obtain informed consent, and randomly assign them by lottery into two groups, with the assessor kept blinded. Group A will receive PNF combined with conventional physiotherapy, involving 20-30-minute sessions three times a week, beginning with a warm-up, followed by PNF techniques such as rhythmic initiation, hold-relax, and slow reversals, and ending with a cool-down to enhance muscle tone, flexibility, and motor control. Group B will receive music therapy along with conventional physiotherapy in 30-minute sessions three times a week, incorporating warm-up sensory regulation, rhythmic auditory stimulation, instrument play, movement-to-music activities, and vocal exercises, concluding with calming music for relaxation. The interventions aim to improve motor coordination, communication, and overall functional outcomes in children with cerebral palsy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

December 11, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

November 29, 2025

Last Update Submit

November 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fall Efficacy Scale

    The Fall Efficacy Scale (FES) measures how confident a person feels performing daily activities without falling.It helps clinicians understand fear of falling and plan treatment to improve safety and independence.

    12 weeks

  • Developmental Coordination Disorder Questionnaire (DCDQ-07)

    The Developmental Coordination Disorder Questionnaire (DCDQ-07) is a parent-report tool used to identify motor coordination difficulties in children aged 5-15. It helps screen for Developmental Coordination Disorder by assessing everyday motor skills at home and school.

    12 weeks

  • GMFCS scale

    It is a five-level scale that describes how children with cerebral palsy move and use mobility aids. It focuses on self-initiated movement-like sitting, standing, and walking-to classify how independently a child functions in daily life.

    12 weeks

Study Arms (2)

(PNF +Conventional physical therapy )

EXPERIMENTAL

Participants in Group A (PNF Therapy) will receive a structured, minimized treatment plan focused on improving muscle tone, flexibility, and motor function while ensuring the sessions remain tolerable for children with CP. Each session, lasting 20-30 minutes, three times per week, will begin with a 5-minute warm-up, including passive stretching and light joint mobilization. The core intervention will consist of 15 minutes of PNF techniques, such as Rhythmic Initiation, where movements transition from passive to active-assisted, Hold-Relax techniques for reducing spasticity through isometric contractions followed by passive stretching, and Slow Reversals, alternating muscle contractions to improve control. Functional movement patterns with minimal resistance will be incorporated to encourage active participation. The session will conclude with a 5-minute cool-down, focusing on gentle stretching and relaxation techniques to promote comfort and prevent fatigue.

Other: (PNF +Conventional physical therapy )Other: Music Therapy + Conventional Physical Therapy

Music Therapy + Conventional Physical Therapy

EXPERIMENTAL

Conversely, participants in Group B (Music Therapy) will engage in 30-minute sessions, three times per week, designed to enhance motor coordination, communication, and emotional well-being through music-based interventions. Each session will start with a 5-10-minute warm-up, incorporating sensory regulation through soft background music, rhythmic swaying, and simple vocal exercises. The 25-minute core intervention will involve Rhythmic Auditory Stimulation (RAS), using rhythmic beats to improve movement control, instrumental play (e.g., drums, xylophone) to enhance upper limb coordination, and movement-to-music activities, such as reaching and stepping in sync with melodies. Additionally, vocal and speech exercises will be incorporated to improve breath control and verbal communication. Sessions will end with a 5-minute cool-down, featuring calming music and gentle tactile stimulation to help the child relax.

Other: (PNF +Conventional physical therapy )Other: Music Therapy + Conventional Physical Therapy

Interventions

Participants in Group A (PNF Therapy) will receive a structured, minimized treatment plan focused on improving muscle tone, flexibility, and motor function while ensuring the sessions remain tolerable for children with CP. Each session, lasting 20-30 minutes, three times per week, will begin with a 5-minute warm-up, including passive stretching and light joint mobilization. The core intervention will consist of 15 minutes of PNF techniques, such as Rhythmic Initiation, where movements transition from passive to active-assisted, Hold-Relax techniques for reducing spasticity through isometric contractions followed by passive stretching, and Slow Reversals, alternating muscle contractions to improve control. Functional movement patterns with minimal resistance will be incorporated to encourage active participation. The session will conclude with a 5-minute cool-down, focusing on gentle stretching and relaxation techniques to promote comfort and prevent fatigue.

(PNF +Conventional physical therapy )Music Therapy + Conventional Physical Therapy

Conversely, participants in Group B (Music Therapy) will engage in 30-minute sessions, three times per week, designed to enhance motor coordination, communication, and emotional well-being through music-based interventions. Each session will start with a 5-10-minute warm-up, incorporating sensory regulation through soft background music, rhythmic swaying, and simple vocal exercises. The 25-minute core intervention will involve Rhythmic Auditory Stimulation (RAS), using rhythmic beats to improve movement control, instrumental play (e.g., drums, xylophone) to enhance upper limb coordination, and movement-to-music activities, such as reaching and stepping in sync with melodies. Additionally, vocal and speech exercises will be incorporated to improve breath control and verbal communication. Sessions will end with a 5-minute cool-down, featuring calming music and gentle tactile stimulation to help the child relax.

(PNF +Conventional physical therapy )Music Therapy + Conventional Physical Therapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with ataxic CP will be eligible for this study if they are between 6 to 18 years of age.
  • Both genders i.e boys and girls will participate.
  • Children diagnosed with ataxic Cerebral Palsy according to SCPE (Surveillance of Cerebral Palsy in Europe characterized ataxix CP as impairments in balance, coordination, and controlled movements) definition and classification
  • CP children with their gross motor function ranging from level 1-3 on GMFCS (ambulatory ).
  • Evidence of impaired balance or risk of fall
  • Both the caregiver and patients are willing to participate in this study.
  • Consent will be taken from guardians or caregivers.

You may not qualify if:

  • Patients below or above the age of 6-18.
  • Patients with Down syndrome or psychiatric problems were excluded.
  • Musculoskeletal problems that contraindicates PNF e.g Juvenile Idiopathic Arthritis (in active phase) and osteogenesis imperfecta .
  • Patients with acute and chronic infectious diseases, coagulation diseases, and progressive cerebral diseases such as neoplasms, surgery from the upper and lower extremity in the last 1 year were excluded.
  • Patients with inherited diseases like trisomy 21 syndrome were excluded.
  • Uncontrolled epilepsy or seizures attack.
  • Severe motor impairment (GMFCS level 5).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Waqar Ul Hassan, MS-MSK

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

September 25, 2025

Primary Completion

February 25, 2026

Study Completion

March 20, 2026

Last Updated

December 11, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations