- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490758
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
August 4, 2022 updated by: Riphah International University
Comparison of Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 40050
- Rising Sun Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sensorimotor training
sensorimotor training group did sensorimotor activities e.g play with dough,peg games 5 days a week for 4 weeks.
|
sensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week.
|
Experimental: constraint induced movement therapy
constraint induced movement therapy group in which affected arm was constraint for 6 hours a day for 5 days a week for 4 weeks.
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constraint induced movement therapy in which arm was constraint for 6 hours a day for 5 days a week for 4 week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nine hole peg test
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
manual ability classification system
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
two point discrimination
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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-+.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 28, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
August 4, 2022
First Posted (Actual)
August 8, 2022
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 4, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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