NCT05252169

Brief Summary

Study Design: Randomized Controlled Trial Settings: Study will be conducted at Mobility quest clinic, Lahore Sample size:37 in each group Control group receive : Routine physical therapy Experimental group receive : Routine physical therapy+proprioceptive training

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
Last Updated

March 17, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 12, 2022

Last Update Submit

March 2, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Balance

    balance will be measured by pediatric balance scale.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

  • Motor Function

    Motor function will be measured by Gross Motor Function Measure 88 scale.It includes scoring key in which 0 means does not initiate and 3 means completely performs the exercise.

    12 weeks

Study Arms (2)

Proprioceptive Training

EXPERIMENTAL

Proprioceptive training will include : Stair climbing up and down,Standing with feet side by side and up and down,one leg standing,Walking heel to toes,Rising from a standard chair. Swiss ball activity will be performed passively by the physical therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation that will be performed with stabilized pelvis and hip. Routine physical therapy will include passive stretching ,strength training and weight bearing exercises. total session will be of 60 minutes.

Other: Proprioceptive trainingOther: Routine Physical therapy

Routine Physical Therapy

PLACEBO COMPARATOR

Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include * Passive stretching exercises * Weight bearing exercises * Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.

Other: Routine Physical therapy

Interventions

Proprioceptive Training will include some active exercises such as stair climbing up and down,one leg standing,Walking heel to toes,rising from a standard chair. And swiss ball training will be applied passively by therapist in which child will sit on the ball and ball will be rolled from side to side,Extension rotation and flexion rotation will be performed to facilitate trunk rotation,Trunk rotation will be performed with stabilized pelvis and hip.

Also known as: Routine physical therapy
Proprioceptive Training

Group A will be given routine physical therapy which will be of 60 minutes each session. The routine physical therapy will include * Passive stretching exercises * Weight bearing exercises * Functional strength training Duration of the treatment will be 3 days a week for 12 weeks i.e., 36 sessions. Each session will be of 60 minutes.

Proprioceptive TrainingRoutine Physical Therapy

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with spastic hemiplegic cerebral palsy ranging from 8 to 14 years. 19
  • Both genders.
  • Gross motor function level II.
  • Children who can follow commands.
  • Pre-diagnosed cerebral palsy subjects of cerebral palsy confirmed by an expert pediatrician.

You may not qualify if:

  • The children with cerebral palsy having co-morbid conditions and contractures that can interfere with recovery will be excluded.
  • The children having severe mental retardation because of difficulty in understanding commands.
  • Any red flag signs (tumor, fracture, metabolic diseases, prolong history of steroidal use.
  • Patients having ventriculoperitonel shunt.
  • Patients unable to travel frequently or as per call from rehab center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mobility Quest Clinic

Lahore, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (4)

  • Brown KE, Neva JL, Ledwell NM, Boyd LA. Use of transcranial magnetic stimulation in the treatment of selected movement disorders. Degener Neurol Neuromuscul Dis. 2014 Dec 4;4:133-151. doi: 10.2147/DNND.S70079. eCollection 2014.

    PMID: 32669907BACKGROUND
  • Newbury DF, Simpson NH, Thompson PA, Bishop DVM. Stage 2 Registered Report: Variation in neurodevelopmental outcomes in children with sex chromosome trisomies: testing the double hit hypothesis. Wellcome Open Res. 2021 Jun 1;3:85. doi: 10.12688/wellcomeopenres.14677.4. eCollection 2018.

    PMID: 30271887BACKGROUND
  • Uwizeye D, Karimi F, Thiong'o C, Syonguvi J, Ochieng V, Kiroro F, Gateri A, Khisa AM, Wao H. Factors associated with research productivity in higher education institutions in Africa: a systematic review. AAS Open Res. 2022 Jan 28;4:26. doi: 10.12688/aasopenres.13211.2. eCollection 2021.

    PMID: 34368619BACKGROUND
  • Ozyurek T, Demiryurek EO. Comparison of the Effectiveness of Different Techniques for Supportive Removal of Root Canal Filling Material. Eur Endod J. 2016 Dec 26;1(1):1-6. doi: 10.5152/eej.2016.16002. eCollection 2016.

    PMID: 32566900BACKGROUND

Study Officials

  • Kinza Amin, MSPTN*

    Univerity of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haider Ullah Khan, MSPTN

CONTACT

Iqra Mubeen, MSPTN

CONTACT

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

February 12, 2022

First Posted

February 23, 2022

Study Start

December 23, 2021

Primary Completion

August 16, 2022

Study Completion

August 26, 2022

Last Updated

March 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations