NCT06011616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

August 21, 2023

Last Update Submit

January 28, 2024

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (18)

  • 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

    Baseline

  • 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

    After 4 weeks

  • 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

    After 8 weeks

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • Manual ability classification system

    Manual ability classification system is used to determine daily use hand activities

    Baseline

  • Manual ability classification system

    Manual ability classification system is used to determine daily use hand activities

    After 4 weeks

  • Manual ability classification system

    Manual ability classification system is used to determine daily use hand activities

    After 8 weeks

  • 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

    Baseline

  • 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

    After 4 weeks

  • 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

    After 8 weeks

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

  • 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.

    Baseline

  • 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.

    After 4 weeks

  • 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.

    After 8 weeks

Study Arms (2)

interventional group

EXPERIMENTAL

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 trainingOther: Motor trainingOther: Conventional exercises

control group

ACTIVE COMPARATOR

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 trainingOther: Conventional exercises

Interventions

Sensory trainingOTHER

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.

interventional group
Motor trainingOTHER

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.

control groupinterventional group
Conventional exercisesOTHER

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

control groupinterventional group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3

You may not qualify if:

  • Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfarabi Special Education Centre/ Physical Health Centre

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kiran Khushnood, MSNMPT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only the subjects would be masked about the group they belong too.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

September 20, 2023

Primary Completion

January 20, 2024

Study Completion

January 25, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)