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

November 18, 2025 updated by: Samah Attia El Shemy, Cairo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • State/Province
      • Cairo, State/Province, Egypt, 3387722
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Hand rehabilitation robotic gloves
robotic gloves assist in hand functions
Other: occupational therapy
designed traditional occupational therapy program
Active Comparator: 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
Other: occupational therapy
designed traditional occupational therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand grip strength by hand held dynamometer
Time Frame: 8 weeks
the hand grip strength will be measured by hand held dynamometer
8 weeks
hand functions ( fine motor precision and integration measured by Bruininks-Oseretsky Test of Motor Proficiency
Time Frame: 8 weeks
hand functions will be measured by Bruininks-Oseretsky Test of Motor Proficiency
8 weeks
wrist joint proprioception by digital goniometer
Time Frame: 8 weeks
wrist joint position sense will be measured by digital goniometer
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Samah Attia El shemy, professor doctor, Cairo university, faculty of physical therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

any participant data will be available on direct request from authors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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