NCT06197594

Brief Summary

Cerebral palsy is a group of upper motor neuron syndromes with acquired disorders of early brain development .It effects the person's ability to move and maintain balance and posture. It is the most common motor disability of childhood. Proprioceptive neuromuscular facilitation integration pattern stimulates the proprioceptors with in the muscle and tendon to enhance the performance flexibility, balance and helps in trunk mobility. The motor control movement pattern is facilitated by the dynamic and assistive active resistant progressions regaining motor control. Rebound therapy is used to facilitate movement, promote balance, helps in increase or decrease in muscle tone and promotes sensory integration. This study will evaluate the effects of PNF techniques with and without rebound therapy on trunk control in children with cerebral palsy. It is randomized controlled trial.34 children with cerebral palsy will participate in this study. The participants will be randomized into control group A (n=17) and experimental group (n =17).Only those children will be included who fulfill inclusion criteria. That is both gender, age range 6 to 12 years, having GMFM score of I -II .Those having cognitive and learning difficulties, having age range out of 6 to 12 years. Data will be analyzed through SPSS 29. The control group will practice PNF techniques for trunk control while experimental group will practice rebound therapy along with PNF exercises for trunk control .Both group will receive 45 min session, 5 days a week for 6 weeks. TCMS and TUG scale will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Cerebral palsy, PNF, Rebound therapy,Trunk Control

Outcome Measures

Primary Outcomes (2)

  • Trunk control measure scale

    Trunk control measuring scale TCMS: Trunk control measuring scale is highly reliable in children with various neuromuscular disorders .It is reliable for children 5 years and older. TCMS consist of static and dynamic sitting balance, the latter is divided into selective movement control and dynamic reaching. TCMS is a valid and reliable tool for assessing the trunk control in children and youth with CP. The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control and 10 to the ability to perform dynamic reaching. The items are scored 0 to 3 with 0 being the inability to perform the task and 3 being the complete task performance.

    6 weeks

  • Timed Up and Go test

    Timed Up and Go test (TUG) It is a performance measure designed to assess the speed of a functional walk. It included stand up, walk 3 min, turn around, walk back, and sit down .It assesses lower limb mobility and function. The TUG test is reliable and responsive measure of balance and mobility for children with CP between 3 and 10 years of age and with GMFM level I- III

    6 weeks

Study Arms (2)

Proprioceptive neuromuscular facilitation techniques

EXPERIMENTAL

GROUP A (experimental group) PNF based exercises for trunk control duration 45 min 5 session/week for 6 weeks; Resist person concentric contraction while move in sitting .Resist eccentric control as th lie down. Balance using stabilizing reversals or rhythmic stabilization .Resist shoulder pelvis ,head.Trunk exercises dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combinations for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion, extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting

Other: Proprioceptive neuromuscular facilitation techniques

Rebound Therapy

ACTIVE COMPARATOR

Rebound Therapy lying down on trampoline bouncing created.10 times.Hip kneeling bounce and Standing bouncing with physio balls .Jump on trampoline. Learning front drops, seat drops for 5 minutes. Resist person concentric contraction while move into sitting .Resist eccentric control as they lie down. Balance using stabilizing reversals to increase trunk stability .Resist shoulder pelvis, head.Trunk exercises: use dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combination for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion , extension ,lateral motion and rotation with trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting

Other: Rebound Therapy

Interventions

Proprioceptive neuromuscular facilitation techniques

Proprioceptive neuromuscular facilitation techniques

Rebound Therapy

Rebound Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both gender
  • Children from 6 years to 12 years of age will be included
  • Degree of spasticity ranged from 1 and 1+ according to modified Ashworth scale
  • According to gross motor functional classification system children were categorized on level I -II
  • Those children should understand and follow simple orders.

You may not qualify if:

  • Child having any fixed deformity of both hands and feet.
  • Having hearing or visual disability
  • Having infectious disease or any open wound
  • Seizures
  • Other spinal deformities
  • Any fracture
  • Unstable cardiac status, Fever greater than 38 degrees Celsius, Any chest infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Germain AM, Blackmore AM, Gibson N, Newell B, Williams SA. Effects of Adaptive Bungee Trampolining for Children With Cerebral Palsy: A Single-Subject Study. Pediatr Phys Ther. 2019 Apr;31(2):165-174. doi: 10.1097/PEP.0000000000000584.

    PMID: 30865143BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Maidah Aiman, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 6, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations