NCT06672328

Brief Summary

This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 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 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 31, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

BalanceCerebral PalsyPhysical Function PerformanceMobilitySpasticity

Outcome Measures

Primary Outcomes (3)

  • Static balance

    Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance.

    8 weeks

  • Dynamic balance

    Pediatrics berg balance scale will be used for balance assessment. It has a total score of 56, with higher scores indicating better balance

    8 weeks

  • Mobility

    GMFM-88 scale will be used for assessment of mobility, particularly the subscales B,D and E related to mobility in sitting, standing and walking stances.

    8 weeks

Study Arms (2)

Interventional Group

EXPERIMENTAL

The participants will receive AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.

Procedure: Training with Action Observation Therapy

Control Group

ACTIVE COMPARATOR

The participants will receive mobility and balance exercises without Action Obseravtion along with conventional therapy consisting of simple lower limb stretchings and strengthening . The AOT-based exercises include different exercises in sitting, standing and turning stances. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.

Procedure: Training without Action Observation Therapy

Interventions

AOT based mobility and balance exercises along with conventional therapy consisting of simple lower limb stretchings and strengthening. The fun based activities inlcude reaching for objects, tower building and taking turns in various stances.

Interventional Group

Cerebral Palsy patients will receive balance and mobility training without action observation in various stances of sitting, standing and turning. Activities are fun based and include reaching for objects, tower building and taking turns in different positions.

Control Group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 5-12.
  • Spastic CP.
  • Modified Ashworth Scale spasticity score 0-2
  • GMFCS level I, II or III.
  • Able to understand and follow commands, e.g. "Stand up, please".
  • Able to sit to stand with or without assistance.

You may not qualify if:

  • Any orthopedic procedure in the past 6 months, that could prevent exercise training.
  • Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
  • History of chronic seizure attacks.
  • Children with severe visual/hearing impairments.
  • Presence of knee contractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ayesha Inam, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

September 10, 2024

Primary Completion

May 15, 2025

Study Completion

May 30, 2025

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations