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Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
sensorimotor training
constraint induced movement therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring sensorimotor training, motor function, constraint induced movement therapy

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subjects who were fully oriented
  • children diagnosed with hemiplegic cerebral palsy
  • no history of intramuscular botulinum injections past one year

Exclusion Criteria:

  • children with epilepsy
  • gross deformity of upper limb
  • children with contractures

Sites / Locations

  • Rising Sun Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sensorimotor training

constraint induced movement therapy

Arm Description

sensorimotor training group did sensorimotor activities e.g play with dough,peg games 5 days a week for 4 weeks.

constraint induced movement therapy group in which affected arm was constraint for 6 hours a day for 5 days a week for 4 weeks.

Outcomes

Primary Outcome Measures

nine hole peg test
nine hole peg test to check hand dexterity and grip. The patient is seated at a table with a container holding nine pegs and a wood/plastic block containing nine empty holes and asked to put the nine pegs in nine holes in a block one by one and then remove the pegs one at a time from the holes and the time is recorded. patient should do the test with both hands independently.

Secondary Outcome Measures

manual ability classification system
it describes how CP child uses his or her hands to handle objects in daily activities with qualitative analysis by care taker, it has five levels. in level 1 child holds objects easily and succesfully. in level 2 child handles most object but with some reduced quality or speed. in level 3 the objects are handled with difficulty and child needs help to prepare or modify activities. in level 4 child handles a limited selection of easily managed objects and always requires some help from others. in level 5 child is not able to handle objects or to complete even simple actions with their hands.

Full Information

First Posted
July 14, 2022
Last Updated
August 4, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05490758
Brief Title
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
Official Title
Comparison of Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy.
Detailed Description
The significance of this study is that there was paucity of literature in finding the comparative effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. The aim is to find out the effects of sensorimotor training on motor functioning of the upper extremity in comparison of constraint induced movement therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
sensorimotor training, motor function, constraint induced movement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sensorimotor training
Arm Type
Experimental
Arm Description
sensorimotor training group did sensorimotor activities e.g play with dough,peg games 5 days a week for 4 weeks.
Arm Title
constraint induced movement therapy
Arm Type
Experimental
Arm Description
constraint induced movement therapy group in which affected arm was constraint for 6 hours a day for 5 days a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
sensorimotor training
Intervention Description
sensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week.
Intervention Type
Other
Intervention Name(s)
constraint induced movement therapy
Intervention Description
constraint induced movement therapy in which arm was constraint for 6 hours a day for 5 days a week for 4 week.
Primary Outcome Measure Information:
Title
nine hole peg test
Description
nine hole peg test to check hand dexterity and grip. The patient is seated at a table with a container holding nine pegs and a wood/plastic block containing nine empty holes and asked to put the nine pegs in nine holes in a block one by one and then remove the pegs one at a time from the holes and the time is recorded. patient should do the test with both hands independently.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
manual ability classification system
Description
it describes how CP child uses his or her hands to handle objects in daily activities with qualitative analysis by care taker, it has five levels. in level 1 child holds objects easily and succesfully. in level 2 child handles most object but with some reduced quality or speed. in level 3 the objects are handled with difficulty and child needs help to prepare or modify activities. in level 4 child handles a limited selection of easily managed objects and always requires some help from others. in level 5 child is not able to handle objects or to complete even simple actions with their hands.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
two point discrimination
Description
two point discrimination to discern that the two nearby objects touching the skin are truly two distant points. it is tested with a sharp object caliper is applied to the exposed skin and response and time are recorded. it is used for tactile perception. the normal minimal distance for the hands is 3cm and 0.6 cm for the fingers tips.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects who were fully oriented children diagnosed with hemiplegic cerebral palsy no history of intramuscular botulinum injections past one year Exclusion Criteria: children with epilepsy gross deformity of upper limb children with contractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising Sun Institute
City
Lahore
State/Province
Punjab
ZIP/Postal Code
40050
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30932166
Citation
Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
Results Reference
background
PubMed Identifier
33393402
Citation
Santana CAS, Tudella E, Rocha NACF, de Campos AC. Lower Limb Sensorimotor Training (LoSenseT) for Children and Adolescents with Cerebral Palsy: A Brief Report of a Feasibility Randomized Protocol. Dev Neurorehabil. 2021 May;24(4):276-286. doi: 10.1080/17518423.2020.1858458. Epub 2021 Jan 3.
Results Reference
background
Citation
Samaei A, Mirshoja MS, Khalili MA. Comparison of Sensorimotor Retraining Methods by Movement Therapy Based on Limitations in Upper Extremity Function in Patients with Chronic Stroke. INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND ALLIED SCIENCES. 2016;5(2):510-+.
Results Reference
background

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Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP

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