NCT06598657

Brief Summary

The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

October 2, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

September 12, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

Talocrural jointMobilization with MovementSpasticity cerebral palsy

Outcome Measures

Primary Outcomes (4)

  • Time Up and Go

    In the TUG test, a child begins in a seated position on a chair or other designated surface. They are instructed to stand up, walk a specific distance (usually three meters or ten feet), turn around, and return to the seated position. The time taken to complete the task is recorded. Evaluation is made by comparing pre and post-intervention. To assess mobility of patient.

    4 weeks

  • 10 m WALK TEST

    The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait. Stopwatch is used and the total time taken to ambulate 6 meters is recorded. Timing starts when the toes pass the 2-meter mark. Timing stops when the toes pass the 8-meter mark. The 6m is then divided by the total time taken (in seconds) to completed. The total time is recorded in m/s

    4 weeks

  • Goniometer

    It is an instrument that measures the available range of motion at a joint.

    4 weeks

  • Modified Ashworth Scale (MAS)

    Modified Ashworth Scale (MAS) is used to assess spasticity. Different grades from 0 to 4 are used to access increased tone and spasticity. With 0 referring to "No increase in tone" and 4 refers to "Affected part rigid in flexion/extension" The measurements are recorded at baseline, during treatment and after treatment protocol.

    4 weeks

Study Arms (2)

Mobilization with Movement MWM of Talocrural joint + Conventional PT

ACTIVE COMPARATOR
Other: Mobilization with Movement MWM

Conventional PT

OTHER
Other: Conventional Treatment

Interventions

Mobilization with Movement MWM of Talocrural joint in non-weight bearing position to improve Dorsiflexion Range of Motion (3 sets of 6 repetitions were applied, with a 1-minute break between sets/3 times a week) and conventional therapy which includes stretching, strengthening, balance training exercise.

Mobilization with Movement MWM of Talocrural joint + Conventional PT

* Stretches of Hamstrings, Gastrocnemius, Soleus and hip adductors with duration of 20 sec hold/ 5 reps and Frequency: 3 times/week. Stretches will be performed passively * Strengthening exercises of Quadriceps and abdominal muscles three times a week. * Static balance exercises including single leg balance, tandem stance, weight shifting with Duration: 10 sec hold/ 5 reps Frequency: 3 times/week

Conventional PT

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both genders
  • Age group 8-18 years
  • Diagnosis of spastic Cerebral Palsy
  • CP to follow verbal directions
  • Modified Ashworth Scale score of '1' or '1+'
  • Function classification system (GMFCS) level I or II ability to walk
  • m or more independently

You may not qualify if:

  • visual, hearing disorders
  • verbal and cognitive disorders (unable to comprehend commands)
  • recent lower extremity surgery
  • botulinum toxin injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAF School for Persons With special Needs PNS, Islamabad

Islamabad, Punjab Province, 46600, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • KINZA ANWAR, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KINZA ANWAR, MS-OMPT

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

October 2, 2024

Primary Completion

September 25, 2025

Study Completion

October 25, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations