NCT06529328

Brief Summary

Brain lesions cause cerebral palsy, a chronic condition that affects movement, posture, and balance. Its causes range in age from pregnancy to postpartum, and they can impact the neurological, musculoskeletal, and sensory systems. This causes problems with balance, movement, and posture. It is essential to intervene early for improved life quality. Maintaining a constant center of gravity within your support base is referred to as balance. Walking is putting one foot on the ground at all times and lifting and lowering each foot in turn. The stability of the trunk and core is necessary for muscle coordination and deliberate motions. A study compares the efficiency of trunk stabilization and core exercises to enhance balance and evaluates mobility changes, such as altered muscle strength, endurance, and gait, as a result of two treatment approaches.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

Cerebral palsy,Balance,Core Stability,Trunk Stabilization.

Outcome Measures

Primary Outcomes (2)

  • Pediatric Reach Test (Pediatric Functional Reach Test)

    Functional Reach will be measured

    8weeks

  • Manual Ability Classification System

    ability of children with cerebral palsy to handle objects with the help of their hands.

    8weeks

Study Arms (2)

Group A

EXPERIMENTAL

For eight weeks, the experimental group in this study will engage in three sessions of thirty to forty-five minutes each, dedicated to core stability exercises that will challenge the muscles of the trunk and abdomen.

Other: core stability

Group B

EXPERIMENTAL

In addition to receiving 25 minutes of conventional therapy, the subjects participated in a 30-minute trunk stabilization exercise program three days a week on non-consecutive days. All tense muscles, including the hamstrings and calf muscles in the lower limb, can benefit from passive stretching exercises. First, it is done five times, then you work your way up to ten repetitions, stretch five times, and finally take five minutes to relax. Extensor muscle strengthening exercises for the back, hips, and knees (for 10 minutes).

Other: core stability

Interventions

In this study the experimental group will perform core stability exercises 3 times per week for an 8-week period and each session of 30 to 45 minutes, the core stability exercises will work on abdominals and trunk muscles with challenges.Subjects received 25 min conventional therapy in addition to 30 30-minute trunk stabilization exercise program conducted for 3 days\\week on non-consecutive days. Passive stretching exercises are applied to all tight muscles, including the hamstrings and calf muscles in the lower limb. It is performed five times initially, building up to ten repetitions, stretching for 5 times, and then allowing relaxation for 5time. Strengthening exercises for back, hip, and knee extensor muscles (for 10 minutes).

Also known as: trunk stability
Group AGroup B

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ● Gender: both girls and boys;
  • ● Age: 2-7 years.
  • ● Diagnosis: spastic CP.
  • ● According to the modified Ashworth scale, the affected lower extremity's degree of spasticity falls between grades 1 and 2.
  • PBS \> 32.

You may not qualify if:

  • ● Got a timing injection with botulinum toxin.
  • ● Epilepsy \| Seizures.
  • ● Lower limb surgery performed throughout the research period.
  • Any deformity or orthopedic condition that affects balance. Deficits in vision and hearing with a MACS score higher than three will not be considered.
  • ● PBS rating less than 32.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.

    PMID: 32053326BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Saba Munir, 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
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be randomized control trail in which nonprobability convenient sampling will be used. two groups of 2 to 7 years age will be formed in which participants will be randomly divided. Group A: will receive , CP children will receive core stability exercises. Group B: Experiment group B, CP children will receive trunk stability exercise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

July 31, 2024

Study Start

June 1, 2024

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations