Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia

NCT ID: NCT07249866

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-02-28

Brief Summary

Statement of the problem:

Does robotic assisted therapy have an effect on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy?

Significance of the study:

New technologies allow and promote active involvement, leading directly to functional changes that are far beyond those obtained with conventional therapy. Many features of robotic therapy may contribute to enhanced recovery of upper limb motor function. These include task-specific practice, intensity of repetition, robotic assistance, enhanced sensory feedback, continual motivation (because every trial yields a degree of success, even if robot assistance is required).

The implementation of robotics with hemiplegic cerebral palsy focuses on functional motor performance by providing intensive repetitive training, sensorimotor integration and cognitive engagement through goal-directed tasks to address the underlying symptoms. Robotic technologies offer numerous potential advantages over conventional therapies, chief among these being the ability to provide high-intensity repetitive training. Robotic treatment is a novel approach that has demonstrated promise in enhancing motor function, enhancing the quality of life, and lessening the burden on caregivers.

Detailed Description

Thirty two children with hemiplegic cerebral palsy from both sexes according to G*power analysis (α= 0.05 , Power= 0.90 , effect size = 0.89) Their ages range from 6- 9 years. Mild to moderate degree of spasticity, according to modified Ashworth scale (grade 1 to 2).

Motor function level will be I and II according to gross motor function classification system.

Assessment will be conducted using Bruininks Oseretsky test of motor proficiency scale 2nd edition (BOT-2) for assessment of fine motor control , handheld dynamometer will be used for measuring hand grip strength and digital goniometer for measuring wrist joint sense of position.

Children in the study group will receive robotic assisted therapy.

Null Hypothesis:

There will be no effect of robotic assisted therapy on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy .

Basic assumptions:

All children will attend the treatment program regularly. All children will follow the same sequence of the treatment procedure. All children will be cooperative and following the instructions during evaluation and treatment procedures.

The results of the study will be helpful for physical therapists dealing with children with the same condition

Inclusion Criteria:

Their ages range from 6-9 years. They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS Their manual abilities will be at level II and Level III according to Manual Ability classification system as mentioned in a previous review They will be able to understand and follow instructions

Exclusion criteria:

Fixed deformity in any joints of the upper limb. Previous history of surgical intervention in the upper limb. Auditory, visual and cognitive problems. Botulinum Toxin injection in last 6 months

Conditions

Cerebral Palsy, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic assisted therapy

robotic hand assisted therapy using robotic gloves for 8 weeks 3seesions / week each session lasts 30 minutes including passive , active assisted, active resisted, mirroring and gaming mode

Group Type: EXPERIMENTAL

Hand rehabilitation robotic gloves

Intervention Type: DEVICE

robotic gloves assist in hand functions

occupational therapy

Intervention Type: OTHER

designed traditional occupational therapy program

Traditional occupational therapy

3 sessions/ week for 8 weeks and each session lasts 30 minutes using scissors - Knocking peg board with hammer- Building towers with rings-- Cubes insertion into wide muzzle jars- Playing with clays and form small balls and rolls

Group Type: ACTIVE_COMPARATOR

occupational therapy

Intervention Type: OTHER

designed traditional occupational therapy program

Interventions

Hand rehabilitation robotic gloves

robotic gloves assist in hand functions

Intervention Type: DEVICE

occupational therapy

designed traditional occupational therapy program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Their ages range from 6-9 years
• They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale
• Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
• Their manual abilities will be at level II and Level III according to Manual Ability classification system
• They will be able to understand and follow instructions

Exclusion Criteria

• Fixed deformity in any joints of the upper limb.
• Previous history of surgical intervention in the upper limb.
• Auditory, visual and cognitive problems.
• Botulinum Toxin injection in last 6 months.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samah Attia El Shemy

professor and chairman of department of physical therapy for pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samah Attia El shemy, professor doctor

Role: PRINCIPAL_INVESTIGATOR

Cairo university, Faculty of physical therapy

Locations

Cairo University

Cairo, State/Province, Egypt

Countries

Egypt

Central Contacts

Mohamed Nour ElDin Hassan, assistant lecturer

Role: CONTACT

mohamed.nooreldien@nub.edu.eg

00201127011865

Facility Contacts

Mohamed Nour

Role: primary

drchess6@gmail.com

01127017865

Other Identifiers

P.T.REC/012/005785

Identifier Type: -

Identifier Source: org_study_id