- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278154
Proprioceptive Neuromuscular Facilitation Versus Music Therapy in Ataxic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 55150
- University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: (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.
|
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.
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.
|
|
Experimental: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Efficacy Scale
Time Frame: 12 weeks
|
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)
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waqar Ul Hassan, MS-MSK, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/12/0003
- 042111865865 (Other Grant/Funding Number: University of Lahore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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