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Not yet recruiting NCT07249866

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

No phase Interventional Cerebral Palsy, Spastic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hand rehabilitation robotic gloves, occupational therapy.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Spastic. Basic parameters: 6 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Device Hand rehabilitation robotic gloves
    robotic gloves assist in hand functions
  • Other occupational therapy
    designed traditional occupational therapy program

Primary outcome measures

  • hand grip strength by hand held dynamometer [Time frame: 8 weeks]
  • hand functions ( fine motor precision and integration measured by Bruininks-Oseretsky Test of Motor Proficiency [Time frame: 8 weeks]
  • wrist joint proprioception by digital goniometer [Time frame: 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07249866 · P.T.REC/012/005785

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗