Cerebral Palsy, SpasticNCT04981964
Altered Back Geometry and Mobility Function After Backward Walking Training in Children With Cerebral Palsy
A study testing Exercise training in people with Cerebral Palsy, Spastic, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: To assess the effect of backward walking training on back geometry and mobility function in children with hemiparetic cerebral palsy through a comparative analysis with forward walking training. BACKGROUND: Spinal deformities are important orthopaedic problems among children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Exercise training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 30 Oct 2021
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranged from 5 to 7 years
- Average height around one meter or more as it is the suitable height for formetric measures
- They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device.
- They were able to understand and follow verbal command. They were classified as I or II by gross motor function classification system (GMFCS).
- The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2.
Who cannot join
- Neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, None Selected, 12611
About this study
Official title: Effect of Forward Versus Backward Walking Training on Back Geometry and Mobility Function in Children With Cerebral Palsy: a Randomized Controlled Study
PURPOSE: To assess the effect of backward walking training on back geometry and mobility function in children with hemiparetic cerebral palsy through a comparative analysis with forward walking training.
BACKGROUND:
Read more
Spinal deformities are important orthopaedic problems among children with cerebral palsy. A detailed evaluation of all these areas when the child first arrives for treatment is essential. The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP. Therefore, the purpose of this study will investigate the role of backward walking training in addition to conventional physiotherapy program on back geometry and mobility function in children with spastic hemiparetic cerebral palsy.
HYPOTHESES: The null hypothesis of this study could be stated as: There will be no statistically significant difference in back geometry and mobility function after adding backward walking training to conventional physical therapy program in spastic hemiparetic cerebral palsy children compared with forward walking training.
RESEARCH QUESTION: Do adding backward walking training to conventional physical therapy program improves back geometry and functional mobility in children with hemiparetic cerebral palsy?
Read the detailed description
Introduction:
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation. It is the most common cause of physical disability during childhood that affects the child on several health dimensions including neuromuscular deficits, such as spasticity, muscle weakness, and decreased selective motor control, and secondary musculoskeletal problems such as bony malformations and contractures.
Trunk impairment is very common but an underscored feature of spastic CP that affects the upper and lower extremity motor functions as well. Impairments associated with the trunk seen in children with CP include but are not limited with decreased stability of the head and trunk, shoulder protraction, spinal curve deviations, and trunk muscle weakness. Inadequate control of trunk muscles leads to compensation of other muscles to maintain the upright posture. Inability of proximal stabilization and increased activation of extremity muscles during postural adjustments reduces their functionality during extremity movements.
Trunk control is the initial frame of reference for postural control; it involves stabilization through selective movements of the trunk. Although trunk control strategies vary depending on the task and the environment, all functional tasks require adequate trunk control. Without the trunk as a stable center, selective movements of the extremities and of the head are profoundly impaired. In children, trunk control ensures the acquisition of basic gross motor skills in order to develop the goal-directed activities that are essential for independent life at home and in the community.
Evaluation of the CP child's passive and active movement of the trunk is an essential part of the evaluation because mobility of the spine in all planes is necessary for correct alignment, smooth and asymmetric movements of the spine and for full range of motion of the extremities. The therapist must document any deviation from normal, note scoliosis, excessive kyphosis and lordosis and whether the curves are structural or functional.
The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP.
Material and methods
Subjects:
A thirty-eight spastic hemiparetic cerebral palsied children of both sexes will participate in this study. The participants will be selected from the out-patient clinic of faculty of physical therapy, Cairo university. All participants will be selected according to the following inclusive criteria: Their age ranged from 5 to 7 years, with average height around one meter or more as it is the suitable height for Formetric measures (because the horizontal line which appears on the computer screen when the camera is ready for recording should be below the scapula to avoid the un-detection of the axillary points which will interfere with recording of the spinal image). They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device. They were able to understand and follow verbal command. They will be classified as I or II by gross motor function classification system (GMFCS). The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2. Exclusion criteria for all participants will be neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial. This study protocol was approved by the research ethical committee of the Faculty of Physical Therapy, Cairo University (P.T.REC/012/002802) and parents will sign a consent form authorizing the child's participation.
The participants will be randomly allocated into 2 groups (group A and B). The participants of group (A) will receive physical therapy program based on neurodevelopmental treatment (NDT) approach, in addition a specially designed forward walking training program. The participants of group (B) will receive the same physical therapy program, in addition a specially designed backward walking training program.
For evaluation:
The assessment will be conducted for each child of both groups individually before and after three successive months of treatment by the same examiner who will be blinded to treatment allocation. The outcome measures will be;
- Formetric instrument system
- Dynamic Gait Index (DGI)
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Exercise training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingProcedure or surgery
both groups received conventional physiotherapy training program, for one hour, three sessions per week, for three successive months, based on neurodevelopmental treatment, composed of approximation of the upper and lower limbs in a regular and rhythmic manner, facilitation of righting, equilibrium and protective reactions, training of postural stability and equal weight shift especially on the affected side, stretching, strengthening exercises for upper and lower limbs and back muscles
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy plus forward walking | Experimental | 25 minutes of the forward walking training program It is based on methods as described by Grecco et al. (2013) The children were instructed to walk at a comfortable, self-selected speed during the first and final five minutes of the session and encouraged to increase the speed during the other 15 minutes. Receives: Procedure: Exercise training |
| Conventional physical therapy plus backward walking | Experimental | 25minutes of the backward walking training It is based on methods as described by Davis (1992) Firstly, the subject is asked to take a step backwards within the parallel bar and can support him or herself with the unaffected hand as required. The therapist provides help to move the subject's leg in the correct pattern, preventing subject from moving the leg back in full extension, when the subject can move the leg back with the correct pattern, the therapist gradually reduces the amount of assistance. Secondly, as the movement components have been practiced and the subjects has taken over actively with only slight help, the therapist facilitates walking backward within the parallel bars. Thirdly, the subject walks backwards actively away from the parallel bars. Finally, the distance and speed of walking backwards is progressively increased. Receives: Procedure: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk imbalance
It represented the lateral deviation of the vertebra prominence from the dimple midpoint. It is measured in millimeters.
Measured: Change from Baseline Trunk imbalance at 3 months
Lateral deviation
The root mean square (RMS) lateral deviation of the spinal midline from the line VP-DM. It is measured in millimeters
Measured: Change from Baseline Lateral deviation at 3 months
Pelvic tilt
The pelvic tilt refers to a height difference of the lumber dimples relative to a horizontal plane. It is measured in millimeters
Measured: Change from Baseline Pelvic tilt at 3 months
Surface rotation
The root mean square (RMS) value of the surface rotation on the symmetry line (in degrees).
Measured: Change from Baseline Surface rotation at 3 months
Pelvic torsion
It is the twisting of the pelvis about a transverse axis (in degrees).
Measured: Change from Baseline Pelvic torsion at 3 months
Secondary outcomes (1)
Mobility function
The Dynamic Gait Index (DGI) will be used to measure mobility function and dynamic balance in walking and stair climbing. There are 8 items on the DGI and each item is scored on a 4-point scale [(3) Normal; (2) Mild impairment; (1) Moderate impairment; (0) Severe impairment] with a maximal score of 24. The 8 items include walking, walking with speed changes, walking with vertical and then horizontal head turns, walking with a quick pivot stop, walking over objects, walking around objects and walking up and down stairs.
Measured: Change from Baseline dynamic gait index at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Almaz Abdel-Aziem, Cairo University
- Investigators
- Amr A Abdel-aziem, Ph.D, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981964
- Sponsor's protocol ID
- P.T.REC/012/002802
- Status last verified
- May 2022
- First submitted
- 25 Jun 2021
- Last updated
- 25 May 2022
- 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 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forward Versus Backward Walking Training on Back Geometry and Mobility Function in Children With Cerebral Palsy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04981964
- Acronym / sponsor ID
- P.T.REC/012/002802
- Conditions
- Cerebral Palsy, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 29 Jul 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.
PURPOSE: To assess the effect of backward walking training on back geometry and mobility function in children with hemiparetic cerebral palsy through a comparative analysis with forward walking training.
BACKGROUND:
Spinal deformities are important orthopaedic problems among children with cerebral palsy. A detailed evaluation of all these areas when the child first arrives for treatment is essential. The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP. Therefore, the purpose of this study will investigate the role of backward walking training in addition to conventional physiotherapy program on back geometry and mobility function in children with spastic hemiparetic cerebral palsy.
HYPOTHESES: The null hypothesis of this study could be stated as: There will be no statistically significant difference in back geometry and mobility function after adding backward walking training to conventional physical therapy program in spastic hemiparetic cerebral palsy children compared with forward walking training.
RESEARCH QUESTION: Do adding backward walking training to conventional physical therapy program improves back geometry and functional mobility in children with hemiparetic cerebral palsy?
Detailed description
Introduction:
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation. It is the most common cause of physical disability during childhood that affects the child on several health dimensions including neuromuscular deficits, such as spasticity, muscle weakness, and decreased selective motor control, and secondary musculoskeletal problems such as bony malformations and contractures.
Trunk impairment is very common but an underscored feature of spastic CP that affects the upper and lower extremity motor functions as well. Impairments associated with the trunk seen in children with CP include but are not limited with decreased stability of the head and trunk, shoulder protraction, spinal curve deviations, and trunk muscle weakness. Inadequate control of trunk muscles leads to compensation of other muscles to maintain the upright posture. Inability of proximal stabilization and increased activation of extremity muscles during postural adjustments reduces their functionality during extremity movements.
Trunk control is the initial frame of reference for postural control; it involves stabilization through selective movements of the trunk. Although trunk control strategies vary depending on the task and the environment, all functional tasks require adequate trunk control. Without the trunk as a stable center, selective movements of the extremities and of the head are profoundly impaired. In children, trunk control ensures the acquisition of basic gross motor skills in order to develop the goal-directed activities that are essential for independent life at home and in the community.
Evaluation of the CP child's passive and active movement of the trunk is an essential part of the evaluation because mobility of the spine in all planes is necessary for correct alignment, smooth and asymmetric movements of the spine and for full range of motion of the extremities. The therapist must document any deviation from normal, note scoliosis, excessive kyphosis and lordosis and whether the curves are structural or functional.
The majority of research in children with CP is focused on assessment and treatment of upper and lower extremities. In contrast, literature on trunk control in children with CP is scarce. Although proximal trunk control is a prerequisite for improving balance and weight symmetry, there is a lack of studies that reported the role of forward and backward walking training in treating the trunk for children with CP.
Material and methods
Subjects:
A thirty-eight spastic hemiparetic cerebral palsied children of both sexes will participate in this study. The participants will be selected from the out-patient clinic of faculty of physical therapy, Cairo university. All participants will be selected according to the following inclusive criteria: Their age ranged from 5 to 7 years, with average height around one meter or more as it is the suitable height for Formetric measures (because the horizontal line which appears on the computer screen when the camera is ready for recording should be below the scapula to avoid the un-detection of the axillary points which will interfere with recording of the spinal image). They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device. They were able to understand and follow verbal command. They will be classified as I or II by gross motor function classification system (GMFCS). The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2. Exclusion criteria for all participants will be neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial. This study protocol was approved by the research ethical committee of the Faculty of Physical Therapy, Cairo University (P.T.REC/012/002802) and parents will sign a consent form authorizing the child's participation.
The participants will be randomly allocated into 2 groups (group A and B). The participants of group (A) will receive physical therapy program based on neurodevelopmental treatment (NDT) approach, in addition a specially designed forward walking training program. The participants of group (B) will receive the same physical therapy program, in addition a specially designed backward walking training program.
For evaluation:
The assessment will be conducted for each child of both groups individually before and after three successive months of treatment by the same examiner who will be blinded to treatment allocation. The outcome measures will be;
- Formetric instrument system
- Dynamic Gait Index (DGI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy plus forward walking | Experimental | Procedure: Exercise training25 minutes of the forward walking training program It is based on methods as described by Grecco et al. (2013) The children were instructed to walk at a comfortable, self-selected speed during the first and final five minutes of the session and encouraged to increase the speed during the other 15 minutes. |
| Conventional physical therapy plus backward walking | Experimental | Procedure: Exercise training25minutes of the backward walking training It is based on methods as described by Davis (1992) Firstly, the subject is asked to take a step backwards within the parallel bar and can support him or herself with the unaffected hand as required. The therapist provides help to move the subject's leg in the correct pattern, preventing subject from moving the leg back in full extension, when the subject can move the leg back with the correct pattern, the therapist gradually reduces the amount of assistance. Secondly, as the movement components have been practiced and the subjects has taken over actively with only slight help, the therapist facilitates walking backward within the parallel bars. Thirdly, the subject walks backwards actively away from the parallel bars. Finally, the distance and speed of walking backwards is progressively increased. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ranged from 5 to 7 years
- Average height around one meter or more as it is the suitable height for formetric measures
- They were able to stand alone independently and have the ability to walk both forward and backward over ground without an assistive device.
- They were able to understand and follow verbal command. They were classified as I or II by gross motor function classification system (GMFCS).
- The degree of spasticity in the involved lower extremity according to Modified Ashworth Scale ranged between grades 1, 1+ and 2.
Key exclusion criteria (1 listed)
- Neurological or orthopedic surgery in the last 12 months, uncontrolled seizure disorder, visual, auditory or perceptual problems and who had any experience of backward training before the trial.
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 |
|---|---|---|
| Exercise trainingboth groups received conventional physiotherapy training program, for one hour, three sessions per week, for three successive months, based on neurodevelopmental treatment, composed of approximation of the upper and lower limbs in a regular and rhythmic manner, facilitation of righting, equilibrium and protective reactions, training of postural stability and equal weight shift especially on the affected side, stretching, strengthening exercises for upper and lower limbs and back muscles | Procedure or surgery | Conventional physical therapy plus backward walking, Conventional physical therapy plus forward walking |
Primary outcome
Trunk imbalance
Time frame: Change from Baseline Trunk imbalance at 3 months
It represented the lateral deviation of the vertebra prominence from the dimple midpoint. It is measured in millimeters.
Lateral deviation
Time frame: Change from Baseline Lateral deviation at 3 months
The root mean square (RMS) lateral deviation of the spinal midline from the line VP-DM. It is measured in millimeters
Pelvic tilt
Time frame: Change from Baseline Pelvic tilt at 3 months
The pelvic tilt refers to a height difference of the lumber dimples relative to a horizontal plane. It is measured in millimeters
Surface rotation
Time frame: Change from Baseline Surface rotation at 3 months
The root mean square (RMS) value of the surface rotation on the symmetry line (in degrees).
Pelvic torsion
Time frame: Change from Baseline Pelvic torsion at 3 months
It is the twisting of the pelvis about a transverse axis (in degrees).
1 secondary outcome
Mobility function
Time frame: Change from Baseline dynamic gait index at 3 months
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 May 2022.
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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.
Amr A Abdel-aziem, Ph.D study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training 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 1 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 May 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?
Trunk imbalance (time frame: Change from Baseline Trunk imbalance at 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 25 May 2022.