Cerebral Palsy, SpasticNCT07249866
Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia
A study testing Hand rehabilitation robotic gloves and occupational therapy in people with Cerebral Palsy, Spastic, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Hand rehabilitation robotic gloves and occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, State/Province, 3387722
Mohamed Nour, 01127017865, drchess6@gmail.com
About this study
Statement of the problem:
Does robotic assisted therapy have an effect on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy?
Read more
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.
Read the 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
- Being tested
- Hand rehabilitation robotic gloves, occupational therapy
- Keywords
- robotic therapy, hand functions, hemiplegia, cerebral palsy
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand rehabilitation robotic glovesDevice
robotic gloves assist in hand functions
occupational therapyOther
designed traditional occupational therapy program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Hand rehabilitation robotic gloves; Other: 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 Receives: Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip strength by hand held dynamometer
the hand grip strength will be measured by hand held dynamometer
Measured: 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
Measured: 8 weeks
wrist joint proprioception by digital goniometer
wrist joint position sense will be measured by digital goniometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Attia El Shemy, Cairo University
- Investigators
- Samah Attia El shemy, professor doctor, Principal investigator, Cairo university, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249866
- Sponsor's protocol ID
- P.T.REC/012/005785
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: any participant data will be available on direct request from authors
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07249866
- Acronym / sponsor ID
- P.T.REC/012/005785
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- robotic therapy, hand functions, hemiplegia, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted therapy | Experimental | Device: Hand rehabilitation robotic gloves, Other: occupational therapyrobotic 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 |
| Traditional occupational therapy | Active comparator | Other: occupational therapy3 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 |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand rehabilitation robotic glovesrobotic gloves assist in hand functions | Device | Robotic assisted therapy |
| occupational therapydesigned traditional occupational therapy program | Other | Robotic assisted therapy, Traditional occupational therapy |
Primary outcome
hand grip strength by hand held dynamometer
Time frame: 8 weeks
the hand grip strength will be measured by hand held dynamometer
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
wrist joint proprioception by digital goniometer
Time frame: 8 weeks
wrist joint position sense will be measured by digital goniometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. any participant data will be available on direct request from authors
Related trials for Cerebral Palsy, Spastic
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
Not yet recruitingObservational study
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
Cerebral Palsy, Sleep Disorders
Recruiting
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
CP (Cerebral Palsy)
Recruiting
Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
Spastic Diplegic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samah Attia El shemy, professor doctor principal investigator
Cairo university, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand rehabilitation robotic gloves and occupational therapy in people with Cerebral Palsy, Spastic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Nour ElDin Hassan, assistant lecturer (00201127011865, mohamed.nooreldien@nub.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand grip strength by hand held dynamometer (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.