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Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sensory training
Motor training
Conventional exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3 Exclusion Criteria: Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year

Sites / Locations

  • Alfarabi Special Education Centre/ Physical Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

interventional group

control group

Arm Description

Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks. Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks

Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks

Outcomes

Primary Outcome Measures

Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Modified Ashworth Scale (MAS)
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Finger Joint Position Sense
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system
Manual ability classification system is used to determine daily use hand activities
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Manual Muscle Testing
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Abilities of Hand (ABILHAND-KIDS)
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Pediatric Arm Function Test
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
August 21, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06011616
Brief Title
Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
Official Title
Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

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
Yes

5. Study Description

Brief Summary
The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.
Detailed Description
The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
Masking
Participant
Masking Description
Only the subjects would be masked about the group they belong too.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional group
Arm Type
Experimental
Arm Description
Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks. Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
Intervention Type
Other
Intervention Name(s)
Sensory training
Intervention Description
sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.
Intervention Type
Other
Intervention Name(s)
Motor training
Intervention Description
Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.
Intervention Type
Other
Intervention Name(s)
Conventional exercises
Intervention Description
stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
Primary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Time Frame
Baseline
Title
Modified Ashworth Scale (MAS)
Description
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Time Frame
After 4 weeks
Title
Modified Ashworth Scale (MAS)
Description
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Time Frame
After 8 weeks
Title
Finger Joint Position Sense
Description
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Time Frame
Baseline
Title
Finger Joint Position Sense
Description
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Time Frame
After 4 weeks
Title
Finger Joint Position Sense
Description
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Time Frame
After 8 weeks
Title
Manual ability classification system
Description
Manual ability classification system is used to determine daily use hand activities
Time Frame
Baseline
Title
Manual ability classification system
Description
Manual ability classification system is used to determine daily use hand activities
Time Frame
After 4 weeks
Title
Manual ability classification system
Description
Manual ability classification system is used to determine daily use hand activities
Time Frame
After 8 weeks
Title
Manual Muscle Testing
Description
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Time Frame
Baseline
Title
Manual Muscle Testing
Description
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Time Frame
After 4 weeks
Title
Manual Muscle Testing
Description
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Time Frame
After 8 weeks
Title
Abilities of Hand (ABILHAND-KIDS)
Description
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Time Frame
Baseline
Title
Abilities of Hand (ABILHAND-KIDS)
Description
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Time Frame
After 4 weeks
Title
Abilities of Hand (ABILHAND-KIDS)
Description
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Time Frame
After 8 weeks
Title
Pediatric Arm Function Test
Description
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Time Frame
Baseline
Title
Pediatric Arm Function Test
Description
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Time Frame
After 4 weeks
Title
Pediatric Arm Function Test
Description
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Time Frame
After 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3 Exclusion Criteria: Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiran Khushnood
Phone
+92 3335993417
Email
kiran.khushnood@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiran Khushnood, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Alfarabi Special Education Centre/ Physical Health Centre
City
Islamabad
State/Province
Islamabad Capital Territory
ZIP/Postal Code
44000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayab Gohar, DPT
Phone
03349513318

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

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