NCT05719623

Brief Summary

Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic. Clinical prediction models and neuroimaging have been used to diagnose CP before the age of 2 years, but further research is necessary. Cuevas Medek Exercises (CME) is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system. According to Ramon Cuevas, who developed the therapy, CME are mainly based on the principle of provoking novel automatic motor reactions using exercises against gravity with progressive distal holding. This study will find the effects of Cuevas Medak Exercises on Balance and Postural control in children with spastic cerebral palsy. This Randomized Controlled Trial will recruit the participants through random sampling. Participants will be randomly divided into 2 groups. Two groups of children aged between 2 and 5 years, suffering from cerebral palsy in spastic form, one for control and one for experiment. Controlled will get conventional treatment while study group will get conventional treatment with Cuevas Medak Exercises. Treatment duration is of 12 weeks. Progress will monitored every month. The frequency of recovery sessions will 3 sessions/week, and the duration of a session will 45 minutes. Patient evaluation will be made at the beginning and the end of the treatment through pediatric balance scale and static balance test. Data will be analyzed through SPSS 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 31, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • pediatric balance scale

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    12 weeks

Secondary Outcomes (1)

  • static balance test.

    12 weeks

Study Arms (2)

CUEVAS MEDEK EXERCISES

EXPERIMENTAL

Experimental group will get conventional treatment along with Cuevas Medak Exercises

Other: CUEVAS MEDEK EXERCISES

BALANCE AND POSTURAL

OTHER

Controlled will get conventional treatment

Other: BALANCE AND POSTURAL

Interventions

stretchings/strengthening

Also known as: Conventional Physical therapy
CUEVAS MEDEK EXERCISES

BALANCE AND POSTURAL

BALANCE AND POSTURAL

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with medical diagnosis of Spastic Cerebral Palsy
  • Age ranging from 2 to 5 years.
  • Children who will able to stand and walk

You may not qualify if:

  • Children with planned surgical or medical surgeries during study period
  • Children with impaired cognition
  • Children with hearing impairment and visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hands Organization (HHRD) Bahawalpur.

Bahawalpur, Punjab Province, 63080., Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Postural Balance

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Sara khan, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 9, 2023

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations