NCT06955247

Brief Summary

Hand skills do not develop in isolation; it is the result of neurologic development, physiologic maturation and adaptation, and functional development of learned patterns of motion and motor learning Hand skills in HCP are very complex and sensitive as it considered the main issue in playing and achieving milestones, so identification of this problem and its solution is very essential and play a miserable rule in adaptive response which is a basis of child's occupation. so, the current study is conducting to investigate the difference between sensory motor integration approach and bobath technique on hand function as manual dexterity, fine motor precision and fine motor integration on children with hemiplegic cerebral palsy

Trial Health

75
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Jan 2027

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

February 27, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

sensory integrationHand function

Outcome Measures

Primary Outcomes (1)

  • Hand functions

    Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition

    45-60 minutes

Secondary Outcomes (1)

  • Spasticity

    10 minutes

Study Arms (2)

Subjects will be randomly allocated in to equal two study groups: - Study group "1" will receiv

EXPERIMENTAL

Subjects will be randomly allocated in to equal two study groups 26 in each group * Study group "1" will receive regular physical therapy for 45 minutes/time in addition to sensory motor integration for 45 minutes/time 3 days per week for 3 months

- Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath

EXPERIMENTAL
Other: bobath technique

Interventions

Study group (1) sensory motor integration for 45 minutes/time ,3 days per week for 3 months Treatment program included two parts; tactile sensation and proprioception stimulation programs. Each of them accounted half of the session and in terms of the type of activity it was divided into three categories: active, passive

\*study group ( 2) bobath techniquefor 45 minutes/time 3 days per week for 3 months in the form of: 1. Preparation phase 2. Intervention program (Movement facilitation \&Functional training)

- Study group "2" will receive regular physical therapy for 45 minutes/time in addition to bobath

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranges from 6 to 12 years.
  • Both genders.
  • Diagnosis of hemiplegia.
  • Level II-III on Manual Ability Classification System (MACS)
  • Spasticity grade 2 to 3 on Modified Ashworth Scale (MAS)
  • Level II-III on Gross Motor Classification System (GMCS)

You may not qualify if:

  • Significant mental or psychological problems.
  • Significant visual/auditory problem.
  • Botox injection and/or surgery of the affected upper limb in the past 12 months.
  • Surgical procedures of the affected upper limb.
  • Fixed deformities in the affected upper limb.
  • Comorbid physical diseases such as myopathy, neuropathy, and other central and peripheral nervous system disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Dokki,Giza Egypt,

Giza, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be randomly allocated in to equal two study groups: * Study group "1" will receive sensory motor integration in addition to regular physical therapy * Study group "2" will receive bobath technique in addition to regular physical therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

February 27, 2025

First Posted

May 2, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations