Cerebral PalsyPeLoGAITNCT00887848
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
A study testing Lokomat training in people with Cerebral Palsy, run by University Children's Hospital, Zurich at 2 sites in Switzerland.
Trial summary
The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Lokomat training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Oct 2009to 14 Aug 2017
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Bilateral spastic cerebral palsy
- Gross Motor Function Classification Scale (GMFCS) II-IV
Who cannot join
- Prior orthopedic surgery on the lower extremity or the trunk (<6 months)
- Prior neurosurgical interventions (<6 months)
- Significant mental retardation
- Severe contractures
- Prior Lokomat training (<6 months)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Zurich, Rehabilitation Centre Affoltern
Affoltern am Albis, CH-8910
Paediatric Therapy Center Reha Rheinfelden
Rheinfelden, Canton of Aargau, CH-4310
About this study
Official title: Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.
Read the detailed description
Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.
Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.
- Conditions
- Cerebral Palsy
- Being tested
- Lokomat training
- Keywords
- Child, Robotic-assisted treadmill training, Rehabilitation
- 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 trainingOther
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
| Study group | Role | What they receive |
|---|---|---|
| Lokomat training | Experimental | Lokomat training Receives: Other: Lokomat training |
| Waiting list | Other | Lokomat training after waiting phase of 5 weeks Receives: Other: Lokomat training |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM-66, section E
Measured: week 0, week 6, week 12
Secondary outcomes (4)
GMFM-66, section D
Measured: week 0, week 6, week 12
Gait speed
Measured: week 0, week 6, week 12
6-minute walk test
Measured: week 0, week 6, week 12
3D gait analysis
Measured: week 0, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study start5 Oct 2009
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Reha Rheinfelden
- Responsible party
- Sponsor
- Investigators
- Corinne Ammann-Reiffer, MPTSc, Principal investigator, University Children's Hospital Zurich, Rehabilitation Center Affoltern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887848
- Sponsor's protocol ID
- PeLoGAIT_2009
- Acronym
- PeLoGAIT
- Status last verified
- Mar 2018
- First submitted
- 23 Apr 2009
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.
PubMed 32444573Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
PubMed 28253887
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
- ClinicalTrials.gov ID
- NCT00887848
- Acronym / sponsor ID
- PeLoGAIT / PeLoGAIT_2009
- Conditions
- Cerebral Palsy
- Keywords
- Child, Robotic-assisted treadmill training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Reha Rheinfelden
- Study start
- 5 Oct 2009 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 24 Apr 2009 (estimated)
- 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.
The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.
Detailed description
Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.
Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lokomat training | Experimental | Other: Lokomat trainingLokomat training |
| Waiting list | Other | Other: Lokomat trainingLokomat training after waiting phase of 5 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Bilateral spastic cerebral palsy
- Gross Motor Function Classification Scale (GMFCS) II-IV
Key exclusion criteria (5 listed)
- Prior orthopedic surgery on the lower extremity or the trunk (<6 months)
- Prior neurosurgical interventions (<6 months)
- Significant mental retardation
- Severe contractures
- Prior Lokomat training (<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 training15 sessions of Lokomat training within 5 weeks (3 trainings/week) | Other | Lokomat training, Waiting list |
Primary outcome
GMFM-66, section E
Time frame: week 0, week 6, week 12
4 secondary outcomes
GMFM-66, section D
Time frame: week 0, week 6, week 12
Gait speed
Time frame: week 0, week 6, week 12
6-minute walk test
Time frame: week 0, week 6, week 12
3D gait analysis
Time frame: week 0, week 6
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 32444573Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.
- Derived from this study: PubMed 28253887Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
- Research projects at the rehabilitation centre Affoltern am Albis, University Children's Hospital ZurichLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Ammann-Reiffer, MPTSc principal investigator
University Children's Hospital Zurich, Rehabilitation Center Affoltern
2 sites 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 University Children's Hospital, Zurich at 2 sites in Switzerland.
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 2 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: stopped early, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 was stopped early (reason given: Recruitment problems). Results are not available in the source record.
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?
GMFM-66, section E (time frame: week 0, week 6, week 12). 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 NCT00887848, which also lists 2 linked publications.
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 30 Mar 2018.