NCT06673849

Brief Summary

Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. These impairments result in changes in muscle growth and hinder the development of motor skills, leading to reduced muscle force generation and decreased flexibility. Spastic cerebral palsy is the most prevalent type, affecting 77% of individuals with CP, and is caused by damage to the motor cortex and pyramidal tracts. The motor cortex is responsible for transmitting voluntary movement signals from the brain to the muscles. Characteristics of spastic cerebral palsy include stiff muscles (hypertonia), which can cause jerky and repetitive limb movements (spasticity). Additionally, individuals with CP often have difficulties in processing somatosensory and proprioceptive information. Proprioceptive training refers to interventions aimed at enhancing proprioceptive function to ultimately improve motor performance, a concept that has been explored in studies focused on sports injuries. In this study, we will utilize two proprioceptive exercises-rhythmic stabilization and ball balancing-to promote functional improvement in the upper extremities of children with spastic CP.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

Ball BalancingCorticobulbar tractsCorticospinal tractsEpilepsyRhythmic StabilizationSpastic CP

Outcome Measures

Primary Outcomes (2)

  • QUEST ( Quality of Upper Extremity Skills Test)

    The Quality of Upper Extremity Skills Test (QUEST) is a reliable and valid tool that assesses hand function and movement patterns in children with cerebral palsy. It can be used with children aged 6 to 12 years (23). The test is conducted in a play environment and consists of 34 activity items. The test assesses four domains: Dissociated movements, Grasp, Protective extension. Reliability is 0.96 and validity is 0.84.

    6 weeks

  • SHUEE Scale

    The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and Effects of Rhythmic Stabilization versus Ball Balancing on Spastic CP 3dynamic positional analysis and assesses the ability to perform grasp and release. The validity is 0.47 and reliability is 0.99

    6 weeks

Study Arms (2)

Rhythmic Stabilization group

EXPERIMENTAL

The CP child will positions his/her upper extremity anywhere in its available range of motion and holds an isometric contraction. The physiotherapist will provide enough resistance to cause the child to react, but not enough to break the isometric contraction. As the child progresses, length of time of rhythmic stabilization increases, the therapist's resistance increases, and amount of contact area between therapist's hands and child's upper extremity decreases. The exercise program consisted of 30-minute sessions per week for six weeks

Other: Rhythmic Stabilization

Ball Balancing group

EXPERIMENTAL

Have the child balance on his/her hands on a 48-inch Gymnastic ball, first with eyes open, then closed. Progress from both hands on one large ball to each hand on separate balls and then to the weaker arm on one ball. Also, progress through the four body positions. With his/her eyes open, then closed. If he/she misses the position, he/she opens his/her eyes and actively moves to the desired position. Use a spotter, especially when doing this exercise for the first time or changing body positions, since the patient may fall off the Gymnastic ball. Start with one repetition of 10 seconds and progress to three to five repetitions of 60 seconds each and this will be done till 6 weeks

Other: Ball Balancing

Interventions

Rhythmic Stabilization Program for Children with Cerebral Palsy Objective: Enhance upper extremity strength and stability through rhythmic stabilization exercises. Program Overview: Duration: 30-minute sessions Frequency: Once per week for 6 weeks Exercise Steps: Positioning: The child positions their upper extremity within their available range of motion. Isometric Contraction: The child holds an isometric contraction, maintaining the position without movement. Therapist's Role: Apply resistance that is sufficient to elicit a reaction but not enough to disrupt the isometric contraction. Progression: Gradually increase the duration of the isometric hold. Increase the amount of resistance applied. Decrease the contact area between the therapist's hands and the child's upper extremity to enhance stability challenges. Monitoring and Adjustments: Assess the child's ability to maintain the contraction and adapt the resistance and support as needed. Encourage the child's engagement.

Rhythmic Stabilization group

Ball Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball Program Details: * Duration: 6 weeks * Frequency: As needed Steps: 1. Initial Balance: * Eyes Open: Balance on hands for 10 seconds. * Progression: Increase to 3-5 repetitions of 60 seconds. 2. Eyes Closed: Repeat the above exercise with eyes closed. 3. Variations: * Both Hands on One Ball * Each Hand on Separate Balls * Weaker Arm on One Ball 4. Body Positions: Progress through four body positions with eyes open, then closed. 5. Correction: If the child misses a position, they open their eyes and reposition actively.

Ball Balancing group

Eligibility Criteria

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

You may qualify if:

  • Spastic diplegic CP children age 6 to 12 years,
  • Each gender included
  • Grade 1 of spasticity according to modified Ashworth scale (21)
  • With normal I.Q. greater than 70 (assessed by psychologist),
  • Can follow commands(

You may not qualify if:

  • Children with any other neurological impairment
  • Children with audio visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

RECRUITING

Related Publications (1)

  • Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.

    PMID: 32206590BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyEpilepsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Masifah Kashif, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study design will be a Randomized Clinical Trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will receive Rhythmic Stabilization exercises and Group B will receive Ball Balancing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

September 25, 2024

Primary Completion

December 2, 2024

Study Completion

January 2, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations