Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06011616

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Sensory training Other: Motor training Other: Conventional exercises	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel

Masking:

Single (Participant)

Masking Description:

Only the subjects would be masked about the group they belong too.

Primary Purpose:

Treatment

Official Title:

Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

Anticipated Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Jan 20, 2024

Anticipated Study Completion Date :

Feb 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: interventional group 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	Other: Sensory training 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. Other: Motor training 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. Other: Conventional exercises stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
Active Comparator: control group Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks	Other: Motor training 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. Other: Conventional exercises stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning

Arm

Intervention/Treatment

Experimental: interventional group

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

Other: Sensory training

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.

Other: Motor training

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.

Other: Conventional exercises

stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning

Active Comparator: control group

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

Other: Motor training

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.

Other: Conventional exercises

stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning

Outcome Measures

Primary Outcome Measures

Modified Ashworth Scale (MAS) [Baseline]
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) [After 4 weeks]
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) [After 8 weeks]
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 [Baseline]
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 [After 4 weeks]
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 [After 8 weeks]
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 [Baseline]
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system [After 4 weeks]
Manual ability classification system is used to determine daily use hand activities
Manual ability classification system [After 8 weeks]
Manual ability classification system is used to determine daily use hand activities
Manual Muscle Testing [Baseline]
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 [After 4 weeks]
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 [After 8 weeks]
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) [Baseline]
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) [After 4 weeks]
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) [After 8 weeks]
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 [Baseline]
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 [After 4 weeks]
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 [After 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alfarabi Special Education Centre/ Physical Health Centre	Islamabad	Islamabad Capital Territory	Pakistan	44000

Sponsors and Collaborators

Riphah International University

Investigators

Study Chair: Kiran Khushnood, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT06011616

Other Study ID Numbers:

RIPHAH/FR&AHS/Letter-014194

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Aug 25, 2023