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NCT Number: NCT07249866

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

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand rehabilitation robotic gloves

Device

robotic gloves assist in hand functions

Occupational Therapy

Other

designed traditional occupational therapy program

Primary outcomes

  1. hand grip strength by hand held dynamometer

    Time frame: 8 weeks

    the hand grip strength will be measured by hand held dynamometer

  2. 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

  3. wrist joint proprioception by digital goniometer

    Time frame: 8 weeks

    wrist joint position sense will be measured by digital goniometer

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Nour ElDin Hassan, assistant lecturer

CONTACT

[email protected]

00201127011865

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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