Cerebral Palsy, SpasticNCT04765917
Effect of Motor Imagery Training on Gait and Balance in Children With Spastic Hemiplegia
A study testing Selected physical Therapy program and Motor imagery training program in people with Cerebral Palsy, Spastic, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to: Investigate the effect of motor imagery training on gait kinematics in children with spastic hemiplegia. Determine the effect of motor imagery training on balance in children with spastic hemiplegia. Assess the effect of motor imagery training on trunk endurance in children with spastic hemiplegia. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Selected physical Therapy program and Motor imagery training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Apr 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their chronological age will be ranged from 7-10 years.
- Their motor function will be at level I according to according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
- The degree of spasticity for these children will ranged from grade 1 to 1+ according to Modified Ashworth Scale (Bohannon and Smith, 1987).
- They will be able to follow instructions during evaluation and treatment.
Who cannot join
- Children will be excluded from the study if they have:
- Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months
- Surgical interference in lower limbs.
- Musculoskeletal problems or fixed deformities in the spine and/or lower extremities.
- Seizures.
- Visual or hearing impairment.
- Mentally retarded children
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy - Cairo University
Cairo, 12316
Eman Kamal, Assistant lecturer, +201017173751, eman_pediatrics2016@yahoo.com
About this study
This study aims to:
- Investigate the effect of motor imagery training on gait kinematics in children with spastic hemiplegia.
- Determine the effect of motor imagery training on balance in children with spastic hemiplegia.
- Assess the effect of motor imagery training on trunk endurance in children with spastic hemiplegia.
Read the detailed description
Children with spastic hemiplegia may experience a variety of concomitant health conditions including, movement difficulty, postural and balance instability, muscle spasticity, difficulty with motor planning and control, and cognitive impairments.
Postural and balance disturbances occur due to the difficulty in maintaining the body segments aligned on narrow base of support and there is limitation in balance recovery in hemiplegic children contributing to delayed responses of ankle muscles, inappropriate sequencing, and increased coactivation of agonists/ antagonists muscles.
Treatment will vary depending on the severity of impairments, level of activity, participation, and on the priorities highlighted by the patient. Walking is often identified as a main goal, and there is evidence that children with hemiplegia can take steps before regaining standing balance, which would support early walking. Many advanced treatment approaches are used to help improve motor function and gait in patients with hemiplegic CP.
Rehabilitation techniques are predominantly focused on alleviating the compromised motor execution facet of action performance, and have not specifically targeted the motor preparation or planning processes. Motor imagery is proposed to be a backdoor mechanism to access the motor system. It being a theoretically feasible method to activate the immature networks involved in motor control. Therefore, for individuals with motor planning problems this cognitive MI training may be useful to improve motor skills.
Although it has been shown to be beneficial in adult patients with stroke, and it still awaits empirical testing in young children with CP.
Despite the potential benefits of motor imagery training, clinical use of motor imagery training for improving walking and balance abilities is not yet common compared with other conventional modalities in rehabilitation of children with hemiplegia. Consequently, more research and further confirmation are needed regarding the impact of motor imagery training on the gait performance, balance and trunk endurance in children with hemiplegia. Therefore, the purpose of this study to investigate the effect of motor imagery training on balance and kinematic parameters of gait in children with hemiplegia.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Selected physical Therapy program, Motor imagery training 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.
Selected physical Therapy programOther
-Facilitation of balance reactions from standing position including: Standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions.
- Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands.
- Strengthening exercises for weakened muscles in upper and lower limbs muscle.
- Strengthening exercises for back and abdominal muscles.
- Stretching exercises for tight muscles in upper and lower limbs.
- Gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs.
- Jumping in place and jumping a board.
Motor imagery training programOther
As a preparation each child will be shown a video of 5 minutes of normal movements.
They will be positioned in a comfortable position. The screen is in the child's visual field. Children will be asked to close their eyes and imagine they will perform the physically practiced task for 10 minutes, similar to one shown in the video. Sequence of the task will be verbally explained to the child for better recalling of sensations in muscles during the movements. During the entire exercise schedule child's attention will be focused on the position, and movement of their body, on proprioceptive inputs coming from the leg muscles and on the tactile sensations of foot floor contact.
Thereafter, the child will be asked to perform the sequence of tasks, rehearsed mentally for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Selected Physical Therapy group | Active comparator | The Control group will receive a selected physical therapy program for 60 minutes, 3 times/week for 3 successive months including the following exercises Receives: Other: Selected physical Therapy program |
| Motor imagery training | Experimental | Children allocated to the study group will receive the same selected physical therapy program given to the control group for 30 min in addition to 30 minutes motor imagery training program Receives: Other: Selected physical Therapy program; Other: Motor imagery training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in Spatial parameters of gait
Analysis of Spatial parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: stride length (cm), Step length (cm).
Measured: "through study completion, an average of 3 months"
Assessing the change in cadence
Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: cadence (number of steps / minute).
Measured: "through study completion, an average of 3 months"
Assessing the change in Angular displacement of joint in gait cycle
Analysis of Angular displacement of joint in gait cycle by using Kinovea software via 2D gait analysis in order to measure the changes in: Ankle dorsiflexion angle in initial contact, hip flexion angle at initial swing and knee extension at midstance. All of these parameters will be measured in degrees.
Measured: "through study completion, an average of 3 months"
Assessing the change in Balance
Evaluation of balance by using HUMAC balance system in order to measure the change in: modified clinical test of sensory integration test (score), limits of stability (score) and weight shift (score). The highest score is (100) and the lower score is (0). The higher scores means a better outcome.
Measured: "through study completion, an average of 3 months"
Assessing the change in walking speed
Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: walking speed (meter / minute).
Measured: "through study completion, an average of 3 months"
Secondary outcomes (1)
Assessing the change in Trunk muscles endurance
Evaluation of trunk muscles endurance by using 3 isometric endurance tests in order to measure the change in trunk muscle endurance via using: Trunk flexion endurance test (seconds), trunk extension endurance test (seconds) and lateral trunk endurance test (seconds)
Measured: "through study completion, an average of 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Apr 2022 (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
- Model description
- 2 different groups receive different interventions at the same time during the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Abdelmoteleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765917
- Sponsor's protocol ID
- Ekamal_phd2021
- Status last verified
- Apr 2021
- First submitted
- 16 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Imagery Training on Gait and Balance in Children With Spastic Hemiplegia
- ClinicalTrials.gov ID
- NCT04765917
- Acronym / sponsor ID
- Ekamal_phd2021
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 23 Feb 2021 (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.
This study aims to:
- Investigate the effect of motor imagery training on gait kinematics in children with spastic hemiplegia.
- Determine the effect of motor imagery training on balance in children with spastic hemiplegia.
- Assess the effect of motor imagery training on trunk endurance in children with spastic hemiplegia.
Detailed description
Children with spastic hemiplegia may experience a variety of concomitant health conditions including, movement difficulty, postural and balance instability, muscle spasticity, difficulty with motor planning and control, and cognitive impairments.
Postural and balance disturbances occur due to the difficulty in maintaining the body segments aligned on narrow base of support and there is limitation in balance recovery in hemiplegic children contributing to delayed responses of ankle muscles, inappropriate sequencing, and increased coactivation of agonists/ antagonists muscles.
Treatment will vary depending on the severity of impairments, level of activity, participation, and on the priorities highlighted by the patient. Walking is often identified as a main goal, and there is evidence that children with hemiplegia can take steps before regaining standing balance, which would support early walking. Many advanced treatment approaches are used to help improve motor function and gait in patients with hemiplegic CP.
Rehabilitation techniques are predominantly focused on alleviating the compromised motor execution facet of action performance, and have not specifically targeted the motor preparation or planning processes. Motor imagery is proposed to be a backdoor mechanism to access the motor system. It being a theoretically feasible method to activate the immature networks involved in motor control. Therefore, for individuals with motor planning problems this cognitive MI training may be useful to improve motor skills.
Although it has been shown to be beneficial in adult patients with stroke, and it still awaits empirical testing in young children with CP.
Despite the potential benefits of motor imagery training, clinical use of motor imagery training for improving walking and balance abilities is not yet common compared with other conventional modalities in rehabilitation of children with hemiplegia. Consequently, more research and further confirmation are needed regarding the impact of motor imagery training on the gait performance, balance and trunk endurance in children with hemiplegia. Therefore, the purpose of this study to investigate the effect of motor imagery training on balance and kinematic parameters of gait in children with hemiplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 different groups receive different interventions at the same time during the study
| Arm | Type | Receives |
|---|---|---|
| Selected Physical Therapy group | Active comparator | Other: Selected physical Therapy programThe Control group will receive a selected physical therapy program for 60 minutes, 3 times/week for 3 successive months including the following exercises |
| Motor imagery training | Experimental | Other: Selected physical Therapy program, Other: Motor imagery training programChildren allocated to the study group will receive the same selected physical therapy program given to the control group for 30 min in addition to 30 minutes motor imagery training program |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their chronological age will be ranged from 7-10 years.
- Their motor function will be at level I according to according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
- The degree of spasticity for these children will ranged from grade 1 to 1+ according to Modified Ashworth Scale (Bohannon and Smith, 1987).
- They will be able to follow instructions during evaluation and treatment.
Key exclusion criteria (8 listed)
- Cardiovascular or respiratory disorders.
- Botulinium muscular injection in the last 6 months
- Surgical interference in lower limbs.
- Musculoskeletal 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 |
|---|---|---|
| Selected physical Therapy program-Facilitation of balance reactions from standing position including: Standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions. * Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands. * Strengthening exercises for weakened muscles in upper and lower limbs muscle. * Strengthening exercises for back and abdominal muscles. * Stretching exercises for tight muscles in upper and lower limbs. * Gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs. * Jumping in place and jumping a board. | Other | Motor imagery training, Selected Physical Therapy group |
| Motor imagery training programAs a preparation each child will be shown a video of 5 minutes of normal movements. They will be positioned in a comfortable position. The screen is in the child's visual field. Children will be asked to close their eyes and imagine they will perform the physically practiced task for 10 minutes, similar to one shown in the video. Sequence of the task will be verbally explained to the child for better recalling of sensations in muscles during the movements. During the entire exercise schedule child's attention will be focused on the position, and movement of their body, on proprioceptive inputs coming from the leg muscles and on the tactile sensations of foot floor contact. Thereafter, the child will be asked to perform the sequence of tasks, rehearsed mentally for 20 minutes. | Other | Motor imagery training |
Primary outcome
Assessing the change in Spatial parameters of gait
Time frame: "through study completion, an average of 3 months"
Analysis of Spatial parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: stride length (cm), Step length (cm).
Assessing the change in cadence
Time frame: "through study completion, an average of 3 months"
Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: cadence (number of steps / minute).
Assessing the change in Angular displacement of joint in gait cycle
Time frame: "through study completion, an average of 3 months"
Analysis of Angular displacement of joint in gait cycle by using Kinovea software via 2D gait analysis in order to measure the changes in: Ankle dorsiflexion angle in initial contact, hip flexion angle at initial swing and knee extension at midstance. All of these parameters will be measured in degrees.
Assessing the change in Balance
Time frame: "through study completion, an average of 3 months"
Evaluation of balance by using HUMAC balance system in order to measure the change in: modified clinical test of sensory integration test (score), limits of stability (score) and weight shift (score). The highest score is (100) and the lower score is (0). The higher scores means a better outcome.
Assessing the change in walking speed
Time frame: "through study completion, an average of 3 months"
Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: walking speed (meter / minute).
1 secondary outcome
Assessing the change in Trunk muscles endurance
Time frame: "through study completion, an average of 3 months"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Faculty of Physical Therapy - Cairo University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected physical Therapy program and Motor imagery training program 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in Spatial parameters of gait (time frame: "through study completion, an average of 3 months"). The study lists 5 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 13 Apr 2021.