Cerebral PalsyRAGTNCT04960683
The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy
A study testing Lokomat training in people with Cerebral Palsy, run by Fatima College of Health Sciences at 1 site in United Arab Emirates.
Trial summary
Need for study There are a few studies published on this topic from various parts of the globe and the results are mixed. Hence further research is required in this area and none of the studies have included samples from the Middle East. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Lokomat training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 8 Nov 2020to 31 Dec 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral palsy with spastic and mix form
- Gross Motor Function Classification System (GMFCS from level II to IV)
- Age 4 to 18
- No contraindications for the training in the Lokomat
- Able to follow simple instructions
Who cannot join
- On botox injection within the last 6 months (as the effect of botox wear out in 6 months)
- Surgery within the last one year
- Fixed contractures and/or with bone instability
- Baclofen infusion pumps in situ
- Seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months);
- Open skin lesions or vascular disorder of lower extremities;
- Having participated in another Lokomat training regime within the previous 3months as well as a change in concomitant treatment within the last 4 weeks before or during the study period
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Fatima College of Health Sciences
Abu Dhabi, 3758
About this study
Need for study
There are a few studies published on this topic from various parts of the globe and the results are mixed. Hence further research is required in this area and none of the studies have included samples from the Middle East.
Read more
Some studies done in this area focus on biomechanical aspects of gait (Cherni, 2018) and our study mainly focuses on functional aspects of gait and quality of life.
Studies done on this area focus highly on gait components and very little is available on the literature on improving balance. Since balance and stability are crucial for walking, it was decided to exclusively assess balance.
Due to a wide range of therapeutic benefits, it is paramount to evaluate the effectiveness of different therapies provided to improve gait.
Aim of the study:
The aim of the proposed research is to investigate the effectiveness of robotic assisted gait training using Lokomat device as an adjunct in improving gait, balance and quality of life in children with cerebral palsy.
Read the detailed description
Background: Gait and balance have been a major issue faced by cerebral palsy children. Cerebral Palsy is the most common condition affecting around 2-2.5 children of 1000 live births (1 in every 400 children) over the last 20 years in the Western world (Levit, 2019). Cerebral Palsy causes complex issues related to physical, psychological and social functions. Active participation and the highest level of independence during daily living are primary goals for cerebral palsy children (Aurich, 2015). One of the major problems that limits activities of daily living is relate to gait and balance in cerebral palsy. From the past one-decade, the popularity of robotic assisted gait training devices have been increasing. There are a studies published on this topic from various parts of the globe and the results are mixed. Recent publications have demonstrated robotic assisted gait training benefits people with cerebral palsy, specifically in increasing walking speed and endurance (Carvalho, 2017). However, the efficacy of robotic assisted gait training in improving gait and balance is not well researched. This study will be the first one in the United Arab Emirates studying the local population and mainly focusing on functional aspects of gait, balance and quality of life.
Aims: The main aim is to investigate the effectiveness of robotic -assisted gait training as an adjunct to traditional physiotherapy to improve gait, balance and quality of life in children with cerebral palsy.
Research hypothesis: Robotic -assisted gait training applied as adjunct to traditional therapy could improve balance, walking and quality of life in children with cerebral palsy.
Methodology: The participants attending the outpatient clinic at Zayed Higher Organization for People of Determination, Abu Dhabi will be invited to take part in the study. They will be randomly allocated to two groups. This study proposes to have 50 participants with at least 25 in each group. The participants will all have spastic form of cerebral palsy as possible with the age of 4-18 years. All the participants will have to have be at Gross Motor Function Classification Level (GMFCS) level I- IV. The robotic -assisted gait training include 5 sessions per week, of 40 min long session during one-month period. The conventional physiotherapy includes 5 sessions per week of 40 min long session during one-month period. The primary analysis will be the pre to post-test differences of the Gross Motor Function Measure (GMFM-88),dimension D \& E, 10 meters walk test, 6 minute walk test, Pediatric Balance Scale, Cerebral palsy Quality of Life questionnaire between experimental and control group.
Data analysis: Data will be statistically analysed using one-way anova. Descriptive statistics and graphic displays will be present for all outcomes for interventions comparing robotic -assisted gait training with traditional physiotherapy training.
- Conditions
- Cerebral Palsy
- Being tested
- Lokomat training
- Keywords
- Children, Lokomat
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat trainingDevice
Also called Conventional therapy
Control group will receive the routine conventional physiotherapy treatment and the treatment for this group consists of the following:
Conventional therapy protocol:
- 5 sessions of 45 minutes a week, each session includes:
- 5 minutes of stretching exercise
- 20 minutes of strengthening exercise
- 10 minutes of balance exercise
- 10 minutes of gait training
Experimental group will receive 45 min of Lokomat in addition to the conventional approach (as explained above). Since Lokomat appointments can be only 8 per day, it is planned to have two groups of 8 participants for 4 weeks each. The Lokomat training include the following:
- 5 sessions of 45 minutes of conventional therapy (same as above) per week
- 5 sessions of 45 minutes on Lokomat per week
| Study group | Role | What they receive |
|---|---|---|
| Robotic -assisted gait training group using Lokomat device | Experimental | * 5 sessions of 40 minutes of conventional therapy and
* 5 sessions of 40 minutes on Lokomat per week Receives: Device: Lokomat training |
| Traditional therapy group | Active comparator | • 5 sessions of 40 minutes of conventional therapy Receives: Device: Lokomat training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure ( GMFM- 88) - dimension D & dimension E
This is the validated test designed to measure change in gross motor function over time in children with cerebral palsy. Dimension D consist of 13 items for standing ability and dimension E has 24 items to assess walking, jumping and running in cerebral palsy children. Its a four point scoring system. Specific descriptors for each score is given in the Manual of GMFM-88.
Measured: Baseline time 0 and up to 8 weeks
6 minute Walk test
The test has been selected as a measure of gait endurance. This is validated test requiring individuals to walk 6 minutes on flat hard floor. Scoring is walking distance.
Measured: Baseline time 0 and up to 8 weeks
10 meters Walk test
The test has been selected as a measure of gait speed. This is validated test requiring individuals to walk on flat hard floor at their comfortable speed for 10 meters.
Measured: Baseline time 0 and up to 8 weeks
Pediatric Balance Scale
14 items valid scale is used to assess functional balance skills in children with spastic cerebral palsy.
Measured: Baseline time 0 and up to 8 weeks
Cerebral Palsy Quality of Life questionnaire for child (CP QOL-child) and Cerebral Palsy Quality of Life questionnaire for adolescent (CP QOL- teen)
This Arabic validated CP QOL- child for age 4-12 and CP QOL- teen for age 13-18 questionnaires are used in the parent version. Its assesses 7 domains on a 9 level point Likert scale.
Measured: Baseline time 0 and up to 8 weeks
Secondary outcomes (3)
Range of motion
Measuring range of motion in hip, knee, ankle joint using the reliable tool called goniometer.
Measured: Baseline time 0 and up to 8 weeks
The Oxford scale
The most commonly used scale for testing muscle strength.
Measured: Baseline time 0 and up to 8 weeks
Modified Ashworth Scale
It is a muscle tone assessment.
Measured: Baseline time 0 and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start8 Nov 2020
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dragana Djuric, Fatima College of Health Sciences
- Investigators
- Dragana Djuric, Principal investigator, FCHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960683
- Sponsor's protocol ID
- INTSTF018PHY20
- Acronym
- RAGT
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2021
- Last updated
- 25 Mar 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 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04960683
- Acronym / sponsor ID
- RAGT / INTSTF018PHY20
- Conditions
- Cerebral Palsy
- Keywords
- Children, Lokomat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fatima College of Health SciencesUniversity, hospital or other
- Study start
- 8 Nov 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 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.
Need for study
There are a few studies published on this topic from various parts of the globe and the results are mixed. Hence further research is required in this area and none of the studies have included samples from the Middle East.
Some studies done in this area focus on biomechanical aspects of gait (Cherni, 2018) and our study mainly focuses on functional aspects of gait and quality of life.
Studies done on this area focus highly on gait components and very little is available on the literature on improving balance. Since balance and stability are crucial for walking, it was decided to exclusively assess balance.
Due to a wide range of therapeutic benefits, it is paramount to evaluate the effectiveness of different therapies provided to improve gait.
Aim of the study:
The aim of the proposed research is to investigate the effectiveness of robotic assisted gait training using Lokomat device as an adjunct in improving gait, balance and quality of life in children with cerebral palsy.
Detailed description
Background: Gait and balance have been a major issue faced by cerebral palsy children. Cerebral Palsy is the most common condition affecting around 2-2.5 children of 1000 live births (1 in every 400 children) over the last 20 years in the Western world (Levit, 2019). Cerebral Palsy causes complex issues related to physical, psychological and social functions. Active participation and the highest level of independence during daily living are primary goals for cerebral palsy children (Aurich, 2015). One of the major problems that limits activities of daily living is relate to gait and balance in cerebral palsy. From the past one-decade, the popularity of robotic assisted gait training devices have been increasing. There are a studies published on this topic from various parts of the globe and the results are mixed. Recent publications have demonstrated robotic assisted gait training benefits people with cerebral palsy, specifically in increasing walking speed and endurance (Carvalho, 2017). However, the efficacy of robotic assisted gait training in improving gait and balance is not well researched. This study will be the first one in the United Arab Emirates studying the local population and mainly focusing on functional aspects of gait, balance and quality of life.
Aims: The main aim is to investigate the effectiveness of robotic -assisted gait training as an adjunct to traditional physiotherapy to improve gait, balance and quality of life in children with cerebral palsy.
Research hypothesis: Robotic -assisted gait training applied as adjunct to traditional therapy could improve balance, walking and quality of life in children with cerebral palsy.
Methodology: The participants attending the outpatient clinic at Zayed Higher Organization for People of Determination, Abu Dhabi will be invited to take part in the study. They will be randomly allocated to two groups. This study proposes to have 50 participants with at least 25 in each group. The participants will all have spastic form of cerebral palsy as possible with the age of 4-18 years. All the participants will have to have be at Gross Motor Function Classification Level (GMFCS) level I- IV. The robotic -assisted gait training include 5 sessions per week, of 40 min long session during one-month period. The conventional physiotherapy includes 5 sessions per week of 40 min long session during one-month period. The primary analysis will be the pre to post-test differences of the Gross Motor Function Measure (GMFM-88),dimension D \& E, 10 meters walk test, 6 minute walk test, Pediatric Balance Scale, Cerebral palsy Quality of Life questionnaire between experimental and control group.
Data analysis: Data will be statistically analysed using one-way anova. Descriptive statistics and graphic displays will be present for all outcomes for interventions comparing robotic -assisted gait training with traditional physiotherapy training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic -assisted gait training group using Lokomat device | Experimental | Device: Lokomat training* 5 sessions of 40 minutes of conventional therapy and * 5 sessions of 40 minutes on Lokomat per week |
| Traditional therapy group | Active comparator | Device: Lokomat training• 5 sessions of 40 minutes of conventional therapy |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Cerebral palsy with spastic and mix form
Key exclusion criteria (7 listed)
- On botox injection within the last 6 months (as the effect of botox wear out in 6 months)
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 |
|---|---|---|
| Lokomat trainingAlso: Conventional therapyControl group will receive the routine conventional physiotherapy treatment and the treatment for this group consists of the following: Conventional therapy protocol: * 5 sessions of 45 minutes a week, each session includes: * 5 minutes of stretching exercise * 20 minutes of strengthening exercise * 10 minutes of balance exercise * 10 minutes of gait training Experimental group will receive 45 min of Lokomat in addition to the conventional approach (as explained above). Since Lokomat appointments can be only 8 per day, it is planned to have two groups of 8 participants for 4 weeks each. The Lokomat training include the following: * 5 sessions of 45 minutes of conventional therapy (same as above) per week * 5 sessions of 45 minutes on Lokomat per week | Device | Robotic -assisted gait training group using Lokomat device, Traditional therapy group |
Primary outcome
Gross Motor Function Measure ( GMFM- 88) - dimension D & dimension E
Time frame: Baseline time 0 and up to 8 weeks
This is the validated test designed to measure change in gross motor function over time in children with cerebral palsy. Dimension D consist of 13 items for standing ability and dimension E has 24 items to assess walking, jumping and running in cerebral palsy children. Its a four point scoring system. Specific descriptors for each score is given in the Manual of GMFM-88.
6 minute Walk test
Time frame: Baseline time 0 and up to 8 weeks
The test has been selected as a measure of gait endurance. This is validated test requiring individuals to walk 6 minutes on flat hard floor. Scoring is walking distance.
10 meters Walk test
Time frame: Baseline time 0 and up to 8 weeks
The test has been selected as a measure of gait speed. This is validated test requiring individuals to walk on flat hard floor at their comfortable speed for 10 meters.
Pediatric Balance Scale
Time frame: Baseline time 0 and up to 8 weeks
14 items valid scale is used to assess functional balance skills in children with spastic cerebral palsy.
Cerebral Palsy Quality of Life questionnaire for child (CP QOL-child) and Cerebral Palsy Quality of Life questionnaire for adolescent (CP QOL- teen)
Time frame: Baseline time 0 and up to 8 weeks
This Arabic validated CP QOL- child for age 4-12 and CP QOL- teen for age 13-18 questionnaires are used in the parent version. Its assesses 7 domains on a 9 level point Likert scale.
3 secondary outcomes
Range of motion
Time frame: Baseline time 0 and up to 8 weeks
The Oxford scale
Time frame: Baseline time 0 and up to 8 weeks
Modified Ashworth Scale
Time frame: Baseline time 0 and up to 8 weeks
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 Mar 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.
Dragana Djuric principal investigator
FCHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat training in people with Cerebral Palsy, run by Fatima College of Health Sciences at 1 site in United Arab Emirates.
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 7 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 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 United Arab Emirates. 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?
Gross Motor Function Measure ( GMFM- 88) - dimension D & dimension E (time frame: Baseline time 0 and up to 8 weeks). 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 Mar 2022.