Proprioceptive Neuromuscular Facilitation Versus Music Therapy in Ataxic Cerebral Palsy

NCT ID: NCT07278154

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2026-03-20

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.

Detailed Description

Recruitment: Participants will be recruited from Physical Therapy Department of University of Lahore Teaching Hospital.

Screening: All the referred participants will be assessed for the eligibility criteria. Patients fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to the study.

Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Pnf technique) and (Group B: Music therapy) by lottery method.

Blinding: This study was a single blinded study in which the assessor was kept blinded.

Intervention:

Group A: (PNF +Conventional physical therapy) 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.

Group B : (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. Throughout the intervention, therapists will adjust session intensity based on each child's tolerance, ensuring a supportive and engaging rehabilitation experience.

Outcome Variables:

• Risk of fall: Fall Efficacy Scale
• Coordination: Developmental Coordination Disorder Questionnaire (DCCQ,07)
• Gross motor function: GMFCS scale

3 sessions per week of 30 minutes will be provided. Data will be assessed by assessor at baseline, at the end of 8th week, 12th week and at the end of 16th week.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(PNF +Conventional physical therapy )

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.

Group Type: EXPERIMENTAL

(PNF +Conventional physical therapy )

Intervention Type: OTHER

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.

Music Therapy + Conventional Physical Therapy

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

(PNF +Conventional physical therapy )

Intervention Type: OTHER

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.

Music Therapy + Conventional Physical Therapy

Intervention Type: OTHER

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.

Interventions

(PNF +Conventional physical therapy )

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Waqar Ul Hassan, MS-MSK

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

042111865865

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UOL/IREB/25/12/0003

Identifier Type: -

Identifier Source: org_study_id