Cerebral PalsyNCT05350241
Repetitive Split-Belt Treadmill Perturbation in Children With Unilateral Cerebral Palsy
A study testing Split-belt treadmill training and Standard physical therapy in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Split-belt treadmill training and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Jan 2021to 7 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral cerebral palsy
- Age 10-16 years
- Motor function level I or II according to the Gross Motor Function Classification System.
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Who cannot join
- Structural deformities/contractures
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders that could be exacerbated by exercise.
- Perceptual and/or behavioral disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Temporospatial Gait Asymmetry, Dynamic Balance, and Locomotor Capacity After a 12-month Split-belt Treadmill Training in Adolescents With Unilateral Cerebral Palsy: A Randomized Clinical Study
This study was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Fifty-two children with ULCP were randomly allocated to the split-belt treadmill walking (n = 26; undergone split-elt treadmill training or the Control group (n =23, received standard rehabilitation program). Both groups were assessed for gait symmetry, dynamic balance control, and locomotor capacity pre and post-treatment.
Read the detailed description
Fifty-two children with ULCP were recruited from the Physical Therapy Outpatient Clinic of the College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 10 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems that could be exacerbated by exercise.
Outcome measures
- Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.
- Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
- Locomotor capacity: This was assessed through the 6-minute walk test (6-MWT), the Timed Up and Down Stair test (TUDS), and the 10-meter Shuttle Run Test (10mSRT).
Both groups were trained for one hour, three times a week, for 12 successive weeks. The split-belt treadmill walking group performed repetitive split-belt treadmill training with an error-augmentation strategy (i.e., exaggeration of the initial step-length asymmetry). The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.
- Conditions
- Cerebral Palsy
- Being tested
- Split-belt treadmill training, Standard physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-belt treadmill trainingOther
Participants in the split-belt walking group (experimental group) performed repeated split-belt treadmill training with an error-augmentation strategy (exaggeration of the initial step-length asymmetry) for 60 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics.
Standard physical therapyOther
Participants in the control group received the standard physical therapy program. Each session lasted for 60 minutes, repeated three times a week, over 12 consecutive weeks. The program consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Split-belt treadmill walking group | Experimental | Participants in this group performed repeated split-belt treadmill training with an error-augmentation strategy. Receives: Other: Split-belt treadmill training |
| Control group | Active comparator | Participants in this group received the standard physical rehabilitation program Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial gait asymmetry index
The spatial gait asymmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Measured: 2 months
Temporal gait asymmetry index
was measured about the single-limb support time of the paretic and non-paretic leg The temporal gait asymmetry index through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Measured: 2 months
Dynamic limit of postural stability
The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.
Measured: 2 months
Secondary outcomes (3)
Six-minute walk test
The six-minute walk test measured the walking distance that children were able to cover across a 30-m walkway with a self-determined walking pace over six minutes. A longer distance indicates a better performance.
Measured: 2 months
Timed Up and Down Stair test
The Timed Up and Down Stair test assessed the capacity (as time in seconds) to walk up and down a stair flight (14 steps, each was 20-cm in height). A shorter time to complete indicates better performance.
Measured: 2 months
10-meter Shuttle Run Test
The 10-meter Shuttle Run Test measured the children's ability to walk and run at a faster rate. The test was performed twice over a 10-m path, and the better (faster) trial was recorded.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start3 Jan 2021
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- A prospective, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350241
- Sponsor's protocol ID
- RHPT/0021/0017
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Temporospatial Gait Asymmetry, Dynamic Balance, and Locomotor Capacity After a 12-month Split-belt Treadmill Training in Adolescents With Unilateral Cerebral Palsy: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05350241
- Acronym / sponsor ID
- RHPT/0021/0017
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 28 Apr 2022 (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 was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Fifty-two children with ULCP were randomly allocated to the split-belt treadmill walking (n = 26; undergone split-elt treadmill training or the Control group (n =23, received standard rehabilitation program). Both groups were assessed for gait symmetry, dynamic balance control, and locomotor capacity pre and post-treatment.
Detailed description
Fifty-two children with ULCP were recruited from the Physical Therapy Outpatient Clinic of the College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 10 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems that could be exacerbated by exercise.
Outcome measures
- Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.
- Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
- Locomotor capacity: This was assessed through the 6-minute walk test (6-MWT), the Timed Up and Down Stair test (TUDS), and the 10-meter Shuttle Run Test (10mSRT).
Both groups were trained for one hour, three times a week, for 12 successive weeks. The split-belt treadmill walking group performed repetitive split-belt treadmill training with an error-augmentation strategy (i.e., exaggeration of the initial step-length asymmetry). The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Split-belt treadmill walking group | Experimental | Other: Split-belt treadmill trainingParticipants in this group performed repeated split-belt treadmill training with an error-augmentation strategy. |
| Control group | Active comparator | Other: Standard physical therapyParticipants in this group received the standard physical rehabilitation program |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Unilateral cerebral palsy
- Age 10-16 years
- Motor function level I or II according to the Gross Motor Function Classification System.
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Key exclusion criteria (5 listed)
- Structural deformities/contractures
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders that could be exacerbated by exercise.
- Perceptual and/or behavioral disorders.
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 |
|---|---|---|
| Split-belt treadmill trainingParticipants in the split-belt walking group (experimental group) performed repeated split-belt treadmill training with an error-augmentation strategy (exaggeration of the initial step-length asymmetry) for 60 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics. | Other | Split-belt treadmill walking group |
| Standard physical therapyParticipants in the control group received the standard physical therapy program. Each session lasted for 60 minutes, repeated three times a week, over 12 consecutive weeks. The program consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises. | Other | Control group |
Primary outcome
Spatial gait asymmetry index
Time frame: 2 months
The spatial gait asymmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Temporal gait asymmetry index
Time frame: 2 months
was measured about the single-limb support time of the paretic and non-paretic leg The temporal gait asymmetry index through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.
Dynamic limit of postural stability
Time frame: 2 months
The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.
3 secondary outcomes
Six-minute walk test
Time frame: 2 months
Timed Up and Down Stair test
Time frame: 2 months
10-meter Shuttle Run Test
Time frame: 2 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 28 Apr 2022.
- 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.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz 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 Split-belt treadmill training and Standard physical therapy in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
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 5 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 28 Apr 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 Saudi Arabia. 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?
Spatial gait asymmetry index (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.