Cerebral Palsy (CP)NCT06520644
Effect Of Virtual Reality On Strength and Coordination in Cerebral Palsy
A study testing Wii-based interactive training program and Traditional physical therapy program in people with Cerebral Palsy (CP), run by Shimaa Mohamed Reffat at 1 site in Egypt.
Trial summary
ABSTRACT: Purpose: To investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis. Materials and methods: This study involved 30 children of both sexes with unilateral cerebral palsy aged ranged 8 up to 10 years. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Wii-based interactive training program and Traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2021to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8-10 years old
- Children were included in the study had Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale[15].
- Motor skill level was at level I and II according to Gross Motor Function Classification System GMFCS[16].
- Able to follow instructions during evaluation and treatment
Who cannot join
- Children were excluded from the study had Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months.
- Surgical interference in lower limbs and/or spine.
- Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
- Seizures
- Visual or hearing impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Interactive Training on Strength and Coordination in Cerebral Palsy
ABSTRACT:
Purpose: To investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis.
Materials and methods: This study involved 30 children of both sexes with unilateral cerebral palsy aged ranged 8 up to 10 years. A designed physical rehabilitation program was given to both groups. furthermore, study group received a wii fit virtual reality-based program. Muscle strength, bilateral coordination, running speed and agility were assessed by using Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2) while hip and knee extensor strength were assessed by lafayette hand-held dynamometer pre and post treatment program.
Read the detailed description
INTRODUCTION Cerebral palsy (CP) is the most common disability of childhood that affects motor function because of injury to the developing brain . Cerebral Palsy is an umbrella term encompassing a heterogeneous group of permanent but not unchanging disorders of movement and posture that is caused by damage to the developing brain .
Children with CP show various motor impairments such as muscle weakness, spasticity, limited range of motion, and loss of selective motor function. These impairments make the development of normal gross motor function difficult. The focus of therapy in CP is to develop enough gross motor function for performing basic life activities independently . children with CP may experience a wide range of lifelong difficulties (such as cognitive impairment, epilepsy, communication difficulties, visual or hearing impairment, progressive musculoskeletal deformities, pain) .
Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking .
Studies have proved that the gross motor skill disorder is an important factor hindering children with CP from participating in physical activities . Components of motor capabilities such as speed, agility, strength, coordination, balance, flexibility, durability are needed by CP. Speed and agility are essential components for the movement of CP. Speed is a qualified ability in addition to strength and endurance. Agility is a psychomotor skill that allows rapid change of movement direction without losing control and balance of movement.
The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21. The BOT-2 had face validity of the items in that they reflect typical childhood motor activities also it had construct validation of the test . Lafayette manual muscle testing system is commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99 .
Virtual reality (VR) is a technology that provides a sense of presence in a real environment with the help of 3D pictures and animations formed in a computer environment and enable the person to interact with the objects in that environment . It was described as an improved form of human-computer interaction that allows the user to be part of and interact with a computer-generated environment . Virtual rehabilitation is a relatively new method in CP treatment that provides CP patients the opportunity to play an interactive game. In the recent years, there has been increasing interest in the use of the Nintendo Wii and Wii Fit (Wii) as virtual rehabilitation tools. This active video games system may allow children with CP to perform many types of activities they cannot do in the real world .
The Nintendo Wii FitTM, a computer game console, is an interesting example of a new exercise choice that could be used for improving strength, flexibility, fitness, postural stability, and general well-being of healthy adult and elderly . However, the main aim of the study to investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis.
MATERIALS AND METHODS Design The study is a randomized controlled trial (RCT) as the selected children were divided randomly by sealed envelopes into two groups of equal number 15 children for each group. The investigator prepared 30 closed envelopes, with each envelope containing a card labeled as either group A or B. Each child legal guardian was asked to draw a closed envelope that determined whether he/she was allocated to Children in group A (control group N=15, Female =8, Male=7) received specially designed physical therapy program. Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training. The sample size for this study was calculated using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test.
Participants Children with hemiparetic CP were recruited from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Thirty children were participating in the study 15 children in each group from both sexes aged 8 up to 10 years.
The study was approved by the Ethical Committee for Human Research at faculty of Physical therapy with reference number P.T. REC/012/003287.Participants legal guardian signed a written informed consent prior to participation in the study.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Wii-based interactive training program, Traditional physical therapy program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii-based interactive training programDevice
include step basic, hula hoop, table tilt, jogging, jumping, single limb extension. Single limb extension
Traditional physical therapy programOther
Facilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy program | Active comparator | Children in group A (control group N=15, Female =8, Male=7)received specially designed physical therapy program.Facilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board. Receives: Other: Traditional physical therapy program |
| Traditional physical therapy program and Wii-based interactive training | Active comparator | Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training.Children in the study group received the same selected physical therapy program given to the control group in addition to 30 minutes Wii-based interactive training program. The frequency of the whole program will be three times per week, for three months.
Nintendo Wii video game consists of console, remote, nunchuck and balance board. The Wii gaming system is based on wireless controller.The games used in this study include step basic, hula hoop, table tilt, jogging, jumping, single limb extension. Receives: Device: Wii-based interactive training program; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2)
The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21[9]. The BOT-2 test consists of four composites and eight subtests including 53 items as follows: Fine manual control (fine motor precision, fine motor integration), Manual coordination (manual dexterity, upper limb coordination), Body Coordination (bilateral coordination, balance), Strength and Agility (running speed and agility, and strength
Measured: through study completion, an average of 1 year
Lafayette manual muscle testing system
commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99
Measured: through study completion ,average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start10 Nov 2021
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- 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
- Model description
- The study is a randomized controlled trial (RCT) as the selected children were divided randomly by sealed envelopes into two groups of equal number 15 children for each group. The investigator prepared 30 closed envelopes, with each envelope containing a card labeled as either group A or B. Each child legal guardian was asked to draw a closed envelope that determined whether he/she was allocated to Children in group A (control group N=15, Female =8, Male=7) received specially designed physical therapy program. Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training. The sample size for this study was calculated using the G\*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shimaa Mohamed Reffat
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Shimaa Mohamed Reffat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520644
- Sponsor's protocol ID
- P.T. REC/012/003287
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interactive Training on Strength and Coordination in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06520644
- Acronym / sponsor ID
- P.T. REC/012/003287
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shimaa Mohamed ReffatUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 25 Jul 2024 (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.
ABSTRACT:
Purpose: To investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis.
Materials and methods: This study involved 30 children of both sexes with unilateral cerebral palsy aged ranged 8 up to 10 years. A designed physical rehabilitation program was given to both groups. furthermore, study group received a wii fit virtual reality-based program. Muscle strength, bilateral coordination, running speed and agility were assessed by using Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2) while hip and knee extensor strength were assessed by lafayette hand-held dynamometer pre and post treatment program.
Detailed description
INTRODUCTION Cerebral palsy (CP) is the most common disability of childhood that affects motor function because of injury to the developing brain . Cerebral Palsy is an umbrella term encompassing a heterogeneous group of permanent but not unchanging disorders of movement and posture that is caused by damage to the developing brain .
Children with CP show various motor impairments such as muscle weakness, spasticity, limited range of motion, and loss of selective motor function. These impairments make the development of normal gross motor function difficult. The focus of therapy in CP is to develop enough gross motor function for performing basic life activities independently . children with CP may experience a wide range of lifelong difficulties (such as cognitive impairment, epilepsy, communication difficulties, visual or hearing impairment, progressive musculoskeletal deformities, pain) .
Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking .
Studies have proved that the gross motor skill disorder is an important factor hindering children with CP from participating in physical activities . Components of motor capabilities such as speed, agility, strength, coordination, balance, flexibility, durability are needed by CP. Speed and agility are essential components for the movement of CP. Speed is a qualified ability in addition to strength and endurance. Agility is a psychomotor skill that allows rapid change of movement direction without losing control and balance of movement.
The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21. The BOT-2 had face validity of the items in that they reflect typical childhood motor activities also it had construct validation of the test . Lafayette manual muscle testing system is commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99 .
Virtual reality (VR) is a technology that provides a sense of presence in a real environment with the help of 3D pictures and animations formed in a computer environment and enable the person to interact with the objects in that environment . It was described as an improved form of human-computer interaction that allows the user to be part of and interact with a computer-generated environment . Virtual rehabilitation is a relatively new method in CP treatment that provides CP patients the opportunity to play an interactive game. In the recent years, there has been increasing interest in the use of the Nintendo Wii and Wii Fit (Wii) as virtual rehabilitation tools. This active video games system may allow children with CP to perform many types of activities they cannot do in the real world .
The Nintendo Wii FitTM, a computer game console, is an interesting example of a new exercise choice that could be used for improving strength, flexibility, fitness, postural stability, and general well-being of healthy adult and elderly . However, the main aim of the study to investigate the effect of interactive training on muscle strength and coordination in children with hemiparesis.
MATERIALS AND METHODS Design The study is a randomized controlled trial (RCT) as the selected children were divided randomly by sealed envelopes into two groups of equal number 15 children for each group. The investigator prepared 30 closed envelopes, with each envelope containing a card labeled as either group A or B. Each child legal guardian was asked to draw a closed envelope that determined whether he/she was allocated to Children in group A (control group N=15, Female =8, Male=7) received specially designed physical therapy program. Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training. The sample size for this study was calculated using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test.
Participants Children with hemiparetic CP were recruited from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Thirty children were participating in the study 15 children in each group from both sexes aged 8 up to 10 years.
The study was approved by the Ethical Committee for Human Research at faculty of Physical therapy with reference number P.T. REC/012/003287.Participants legal guardian signed a written informed consent prior to participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a randomized controlled trial (RCT) as the selected children were divided randomly by sealed envelopes into two groups of equal number 15 children for each group. The investigator prepared 30 closed envelopes, with each envelope containing a card labeled as either group A or B. Each child legal guardian was asked to draw a closed envelope that determined whether he/she was allocated to Children in group A (control group N=15, Female =8, Male=7) received specially designed physical therapy program. Children in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training. The sample size for this study was calculated using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test.
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy program | Active comparator | Other: Traditional physical therapy programChildren in group A (control group N=15, Female =8, Male=7)received specially designed physical therapy program.Facilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board. |
| Traditional physical therapy program and Wii-based interactive training | Active comparator | Device: Wii-based interactive training program, Other: Traditional physical therapy programChildren in group B (study group=15, Female =10, Male=5) received the same program given to (group A) in addition to Wii-based interactive training.Children in the study group received the same selected physical therapy program given to the control group in addition to 30 minutes Wii-based interactive training program. The frequency of the whole program will be three times per week, for three months. Nintendo Wii video game consists of console, remote, nunchuck and balance board. The Wii gaming system is based on wireless controller.The games used in this study include step basic, hula hoop, table tilt, jogging, jumping, single limb extension. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 8-10 years old
- Children were included in the study had Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale[15].
- Motor skill level was at level I and II according to Gross Motor Function Classification System GMFCS[16].
- Able to follow instructions during evaluation and treatment
Key exclusion criteria (6 listed)
- Children were excluded from the study had Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months.
- Surgical interference in lower limbs and/or spine.
- Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
- Seizures
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 |
|---|---|---|
| Wii-based interactive training programinclude step basic, hula hoop, table tilt, jogging, jumping, single limb extension. Single limb extension | Device | Traditional physical therapy program and Wii-based interactive training |
| Traditional physical therapy programFacilitation of balance reactions from standing position including; standing on balance board, standing on one leg, weights shifting from standing position and stoops and recover from standing,Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands,Gait training activities including: walking on balance board, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs,Facilitation of protective reaction from standing position by pushing the child in different directions.Facilitation of rising mechanism through changing position e.g.: from lying to standing and from sitting to standing,Strengthening exercises for back and abdominal muscles as well as upper and lower limbs,Jumping in place and jumping a board. | Other | Traditional physical therapy program, Traditional physical therapy program and Wii-based interactive training |
Primary outcome
Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2)
Time frame: through study completion, an average of 1 year
The BOT-2 is norm-referenced, and it involves individually administered tasks with direct observation and assessment of a child in a structured environment. Evidence supporting the use of the BOT-2 to assess gross and fine motor proficiency of individuals aged 4 through 21[9]. The BOT-2 test consists of four composites and eight subtests including 53 items as follows: Fine manual control (fine motor precision, fine motor integration), Manual coordination (manual dexterity, upper limb coordination), Body Coordination (bilateral coordination, balance), Strength and Agility (running speed and agility, and strength
Lafayette manual muscle testing system
Time frame: through study completion ,average of 1 year
commonly used device that measure isometric lower limb muscle strength. Handheld dynamometer is used to assess lower limb strength. The test-retest interclass correlation coefficient ranged from 0.95 to 0.99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii-based interactive training program and Traditional physical therapy program in people with Cerebral Palsy (CP), run by Shimaa Mohamed Reffat 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky test of motor proficiency, 2nd edition (BOT-2) (time frame: through study completion, an average of 1 year). The study lists 2 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 Jul 2024.