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Proprioceptive Training,Balance,Motor Function,Spastic Cerebral Palsy Patient

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive training
Routine Physical therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Sites / Locations

  • Mobility Quest ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Proprioceptive Training

Routine Physical Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2022
Last Updated
March 2, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05252169
Brief Title
Proprioceptive Training,Balance,Motor Function,Spastic Cerebral Palsy Patient
Official Title
Effects of Proprioceptive Training on Balance and Motor Function in Children With Spastic Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
August 16, 2022 (Anticipated)
Study Completion Date
August 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Control group : Group A will be control group 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. Experimental group : Routine physical therapy+proprioceptive training. Group B will be given proprioceptive 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 each session. The Proprioceptive training included the following exercises. Stair climbing up and down (a regular 3 steps staircase). Standing with feet approximately shoulder-width apart and arms extended out slightly forward lower than the shoulder, then lifting both heel off the floor and to hold the position for 10 seconds, followed by climbing regular steps staircase. This procedure will be performed with eyes closed also. Standing with feet side by side & holding the arms in same position as described above, one foot is placed on the inside of the opposing ankle and to hold the position for 10 seconds. Followed by climbing regular steps staircase. This procedure will be performed will be eyes closed also. To perform one leg standing with one foot raised to the back and to maintain the position for minimum 3 seconds. This procedure will be performed with eyes closed also. Same exercise as above performed but with one foot raised to the front. This procedure will be then performed with eyes closed. Walking heel to toes. Rising from a standard chair (4 times) without arm support. For proprioception Swiss ball will be use as a modality and it will be performed passively by the physical therapist.For this physical therapist will be on the front of the subject different activities will be performed in different positions. For posture control development 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. Reaching activities will be done in different directions that will allow the child to work on trunk and lateral weight shifting. Position the child supine on the ball with the feet to the floor. Hold through the lower abdominals to stabilize them on to the ball. Now facilitate through one arm and bring the child diagonally up to stance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Physical Therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proprioceptive training
Other Intervention Name(s)
Routine physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
12 weeks
Title
Motor Function
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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. Exclusion Criteria: • 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Haider Ullah Khan, MSPTN
Phone
03314127210
Email
haiderullah@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Iqra Mubeen, MSPTN
Phone
03337222754
Email
iqra.awan28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kinza Amin, MSPTN*
Organizational Affiliation
Univerity of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mobility Quest Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Waqar Afzal, Phd*
Phone
03214668377
Email
waqar.afzal@uipt.uol.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32669907
Citation
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.
Results Reference
background
PubMed Identifier
30271887
Citation
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.
Results Reference
background
PubMed Identifier
34368619
Citation
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.
Results Reference
background
PubMed Identifier
32566900
Citation
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.
Results Reference
background

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Proprioceptive Training,Balance,Motor Function,Spastic Cerebral Palsy Patient

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