Cerebral Palsy, SpasticNCT04761263
Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia
A study testing Task-oriented circuit training and Selected Physical therapy program in people with Cerebral Palsy, Spastic, run by Horus University at 1 site in Egypt.
Trial summary
Statement of the problem: Does task-oriented circuit training have an effect on kinematic parameters of gait, pelvic symmetry and trunk endurance in children with hemiplegic CP? Purpose of the study: This study aims to: Investigate the effect of exercise-based task-oriented circuit training on gait kinematics… 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?
- Task-oriented circuit training and Selected Physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2021to 15 Mar 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 age will be ranged from 7-10 years.
- Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
- The degree of spasticity will range from mild to moderate 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:
- Other types of cerebral palsy.
- 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.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo University
Cairo, 34518
About this study
Statement of the problem:
Does task-oriented circuit training have an effect on kinematic parameters of gait, pelvic symmetry and trunk endurance in children with hemiplegic CP?
Read more
Purpose of the study:
This study aims to:
- Investigate the effect of exercise-based task-oriented circuit training on gait kinematics including (Stride length, step length, cadence, walking speed, ankle dorsiflexion angle in initial contact, knee extension angle in midstance and hip extension angle in terminal stance) in children with hemiplegic CP.
- Determine the effect of task-oriented circuit training on pelvic symmetry including (Anterior and lateral pelvic tilting) in children with hemiplegic CP.
- Examine the effect of task-oriented circuit training on trunk endurance including (prone plank test, timed partial curl up test, front abdominal power test and unilateral supine bridge test) in children with hemiplegic CP.
Read the detailed description
Children with CP have lowered physical fitness levels because their motor impairments restrict their participation in daily physical activities. Children with hemiplegic CP 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. They also have diminished force generation, debilitated proprioception around the core, lack of enough harmonization in core musculature, and diminished capacity to adjust coupling between the trunk, pelvis, and hip stabilizers leading to diminished proficiency of movement.
According to the concept of motor learning, training is considered to be most effective when the training task is specific to the intended outcome, as optimal improvement in function involves the practice of task-specific activities. Due to the shift in focus on functional movements rather than muscle activity or movement patterns, there has been a task-oriented approach which is based on the system model of motor control providing motivation due to specific achievements that can be made.
Task-oriented circuit training effectively provides various sensory stimulation and promotes functional activities for stroke patients; however, more attention is becoming directed to children with CP to examine the effect of the task-oriented circuit training program on functional performance in children with CP. Therefore, the aim of this study is to determine the effect of rehabilitation delivered as a task-oriented circuit exercise program on kinematic parameters of gait, pelvic symmetry, and trunk endurance in children with hemiplegic CP.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Task-oriented circuit training, Selected Physical therapy program
- Keywords
- hemiplegic cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented circuit trainingOther
The task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child's ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement.
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 and standing on balance board.
- 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 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 as well as returning back to the original 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 |
|---|---|---|
| Selected Physical Therapy group | Active comparator | will receive a selected physical therapy program for 90 minutes, 3 times/week for 3 successive months. Receives: Other: Selected Physical therapy program |
| Task-oriented circuit training group | Experimental | Children allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months. Receives: Other: Task-oriented circuit training; Other: Selected Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in Angular displacement of joints during gait cycle
assessment via using 2D gait analysis by Kinovea software in order to measure change in angular displacement of joints during gait cycle including: angle of ankle dorsiflexion at initial contact, angle of knee extension at midstance and angle of hip extension during terminal stance. All of these measurements have the same unit which is (angle in degrees)
Measured: at baseline and after 3 months of intervention
Assessing the change in Pelvic symmetry
by using palpation meter inclinometer to measure the change in anterior and lateral pelvic tilting angles in degrees
Measured: at baseline and after 3 months of intervention
Assessing the change in spatial parameters of gait
assessment via using 2D gait analysis by Kinovea software in order to measure change in step length and stride length in centimeters.
Measured: at baseline and after 3 months of intervention
Assessing the change in Temporal parameters of gait
assessment via using 2D gait analysis by Kinovea software in order to measure change in cadence (number of steps/minute) and walking speed (meter/minute)
Measured: at baseline and after 3 months of intervention
Secondary outcomes (1)
Assessing the change in Trunk muscles endurance
Endurance of the trunk muscles will be evaluated using four endurance tests designed to establish the change in isometric trunk muscles endurance including; prone plank test (sec), timed partial curl up test (sec), front abdominal power test (cm) and unilateral supine bridge test (sec). For each trunk endurance measure, the examiner will instruct the child to hold the test position as long as possible prior to all testing. Each position will be tested three times and the average time will be recorded.
Measured: at baseline and after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start7 Feb 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- two different groups received different interventions at the same time
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El-Sayed, Horus University
- Investigators
- Mohamed El-Sayed, Assistant lecturer, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761263
- Sponsor's protocol ID
- melsayed_phd2021
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Sayed MS, Kilany A, El Shemy SA. Efficacy of Task-Oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Trunk Endurance in Children with Hemiplegia: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2025 Mar 1;25(1):36-46. doi: 10.22540/JMNI-25-036.
PubMed 40024226
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task-oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Endurance in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT04761263
- Acronym / sponsor ID
- melsayed_phd2021
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- hemiplegic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 18 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.
Statement of the problem:
Does task-oriented circuit training have an effect on kinematic parameters of gait, pelvic symmetry and trunk endurance in children with hemiplegic CP?
Purpose of the study:
This study aims to:
- Investigate the effect of exercise-based task-oriented circuit training on gait kinematics including (Stride length, step length, cadence, walking speed, ankle dorsiflexion angle in initial contact, knee extension angle in midstance and hip extension angle in terminal stance) in children with hemiplegic CP.
- Determine the effect of task-oriented circuit training on pelvic symmetry including (Anterior and lateral pelvic tilting) in children with hemiplegic CP.
- Examine the effect of task-oriented circuit training on trunk endurance including (prone plank test, timed partial curl up test, front abdominal power test and unilateral supine bridge test) in children with hemiplegic CP.
Detailed description
Children with CP have lowered physical fitness levels because their motor impairments restrict their participation in daily physical activities. Children with hemiplegic CP 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. They also have diminished force generation, debilitated proprioception around the core, lack of enough harmonization in core musculature, and diminished capacity to adjust coupling between the trunk, pelvis, and hip stabilizers leading to diminished proficiency of movement.
According to the concept of motor learning, training is considered to be most effective when the training task is specific to the intended outcome, as optimal improvement in function involves the practice of task-specific activities. Due to the shift in focus on functional movements rather than muscle activity or movement patterns, there has been a task-oriented approach which is based on the system model of motor control providing motivation due to specific achievements that can be made.
Task-oriented circuit training effectively provides various sensory stimulation and promotes functional activities for stroke patients; however, more attention is becoming directed to children with CP to examine the effect of the task-oriented circuit training program on functional performance in children with CP. Therefore, the aim of this study is to determine the effect of rehabilitation delivered as a task-oriented circuit exercise program on kinematic parameters of gait, pelvic symmetry, and trunk endurance in children with hemiplegic CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two different groups received different interventions at the same time
| Arm | Type | Receives |
|---|---|---|
| Selected Physical Therapy group | Active comparator | Other: Selected Physical therapy programwill receive a selected physical therapy program for 90 minutes, 3 times/week for 3 successive months. |
| Task-oriented circuit training group | Experimental | Other: Task-oriented circuit training, Other: Selected Physical therapy programChildren allocated to the study group will receive the same selected physical therapy program given to the control group for 45 minutes in addition to 45 minutes task-oriented circuit training program. The frequency of the whole program will be three times per week, for three months. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their age will be ranged from 7-10 years.
- Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
- The degree of spasticity will range from mild to moderate 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)
- Other types of cerebral palsy.
- 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.
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 |
|---|---|---|
| Task-oriented circuit trainingThe task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child's ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement. | Other | Task-oriented circuit training group |
| 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 and standing on balance board. * 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 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 as well as returning back to the original 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 | Selected Physical Therapy group, Task-oriented circuit training group |
Primary outcome
Assessing the change in Angular displacement of joints during gait cycle
Time frame: at baseline and after 3 months of intervention
assessment via using 2D gait analysis by Kinovea software in order to measure change in angular displacement of joints during gait cycle including: angle of ankle dorsiflexion at initial contact, angle of knee extension at midstance and angle of hip extension during terminal stance. All of these measurements have the same unit which is (angle in degrees)
Assessing the change in Pelvic symmetry
Time frame: at baseline and after 3 months of intervention
by using palpation meter inclinometer to measure the change in anterior and lateral pelvic tilting angles in degrees
Assessing the change in spatial parameters of gait
Time frame: at baseline and after 3 months of intervention
assessment via using 2D gait analysis by Kinovea software in order to measure change in step length and stride length in centimeters.
Assessing the change in Temporal parameters of gait
Time frame: at baseline and after 3 months of intervention
assessment via using 2D gait analysis by Kinovea software in order to measure change in cadence (number of steps/minute) and walking speed (meter/minute)
1 secondary outcome
Assessing the change in Trunk muscles endurance
Time frame: at baseline and after 3 months of intervention
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 22 Mar 2022.
- Derived from this study: PubMed 40024226El-Sayed MS, Kilany A, El Shemy SA. Efficacy of Task-Oriented Circuit Training on Gait Kinematics, Pelvic Symmetry and Trunk Endurance in Children with Hemiplegia: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2025 Mar 1;25(1):36-46. doi: 10.22540/JMNI-25-036.
- Individual participant dataSharing planned: No
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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.
Mohamed El-Sayed, Assistant lecturer principal investigator
Horus University in 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 Task-oriented circuit training and Selected Physical therapy program in people with Cerebral Palsy, Spastic, run by Horus 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: finished, as of the sponsor's last update on 22 Mar 2022. 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?
Assessing the change in Angular displacement of joints during gait cycle (time frame: at baseline and after 3 months of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761263, which also lists 1 linked publication.
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 22 Mar 2022.