NCT05490758

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

Study Start

First participant enrolled

May 18, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

28 days

First QC Date

July 14, 2022

Last Update Submit

August 4, 2022

Conditions

Hemiplegic Cerebral Palsy

Keywords

sensorimotor trainingmotor functionconstraint induced movement therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • manual ability classification system

    4 weeks

Other Outcomes (1)

  • two point discrimination

    4 weeks

Study Arms (2)

sensorimotor training

EXPERIMENTAL

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

Other: sensorimotor training

constraint induced movement therapy

EXPERIMENTAL

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

Other: constraint induced movement therapy

Interventions

sensorimotor trainingOTHER

sensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week.

sensorimotor training
constraint induced movement therapyOTHER

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

constraint induced movement therapy

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute

Lahore, Punjab Province, 40050, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 30932166BACKGROUND

  • 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.

    PMID: 33393402BACKGROUND

  • 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-+.

    BACKGROUND

MeSH Terms

Interventions

Constraint Induced Movement Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

August 8, 2022

Study Start

May 18, 2022

Primary Completion

June 15, 2022

Study Completion

June 28, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)