NCT07249866

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

August 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 25, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 25, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

robotic therapyhand functionshemiplegiacerebral palsy

Outcome Measures

Primary Outcomes (3)

  • hand grip strength by hand held dynamometer

    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

    hand functions will be measured by Bruininks-Oseretsky Test of Motor Proficiency

    8 weeks

  • wrist joint proprioception by digital goniometer

    wrist joint position sense will be measured by digital goniometer

    8 weeks

Study Arms (2)

Robotic assisted therapy

EXPERIMENTAL

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 glovesOther: occupational therapy

Traditional occupational therapy

ACTIVE COMPARATOR

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

Interventions

robotic gloves assist in hand functions

Robotic assisted therapy

designed traditional occupational therapy program

Robotic assisted therapyTraditional occupational therapy

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, State/Province, 3387722, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Samah Attia El shemy, professor doctor

    Cairo university, Faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Nour ElDin Hassan, assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor and chairman of department of physical therapy for pediatrics

Study Record Dates

First Submitted

August 25, 2025

First Posted

November 25, 2025

Study Start

November 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

November 25, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

any participant data will be available on direct request from authors

Locations