Spinal Cord InjuryNCT01989806
Robotic-assisted Locomotor Training on Mobility and Cardiopulmonary Function in Patients Suffering From Spinal Cord Injury
A study testing Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) and Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) in people with Spinal Cord Injury, run by Kowloon Hospital, Hong Kong at 1 site in China.
Trial summary
Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and shorter life expectancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) and Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient with age 18 or above
- suffering from incomplete spinal cord injury with classification B, C or D under the International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI)
- lesion level above or at T12; acquired the injury not more than 24 months at the time of recruitment
- traumatic or non-traumatic, non-progressive lesion
- able to tolerate standing on tilt-table in 90 degrees for more than 30 minutes
- able to walk with or without orthosis but requires manual assistance in walking.
Who cannot join
- fracture of spine or lower limbs which is not yet stabilized
- severe osteoporosis or at high risk of pathological fracture
- symptomatic postural hypotension; cardiac disease which is not recommended for moderate intensity exercise
- severe muscle spasticity over lower limbs
- severe lower limbs fixed contractures
- leg length discrepancy for more than 2 centimeters
- body weight exceeding 135 kilograms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Effect of Robotic-assisted Body Weight Supported Treadmill Training on Walking and Cardiopulmonary Recovery in Patients Suffering From Incomplete Spinal Cord Injury
Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and shorter life expectancy. Different modalities were developed aiming at mobility restoration in SCI patients and robotic assisted body weight supported treadmill training is one of the latest technique in recent years. Yet there are scarce studies to investigate its effectiveness. The purpose of this study is to investigate the effectiveness of robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary function of patients suffering from SCI by a randomized controlled trial.
80 patients suffering from incomplete SCI will be recruited for an 8-week training program. They will be randomized into either robotic assisted body weight supported treadmill training group or passive lower limb mobilization training group. The training effects will be measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score, lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under sub maximal exercise stress test.
Read more
Through the study, we intent to find the effectiveness of robotic-assisted body weight support treadmill training on walking and cardiopulmonary recovery with patients suffering from incomplete spinal cord injury.
The hypothesis of the study is:
Compared to the control group, robotic-assisted body weight supported treadmill training leads to a greater improvement in walking ability and cardiopulmonary functioning.
Read the detailed description
Participants will be recruited from the spinal cord rehabilitation unit of Physiotherapy Department of Kowloon Hospital. Subjects will be allocated into intervention group or control group by using sealed envelope and they will be blinded for their group allocation. All participants will undergo standard physiotherapy program, including mobilization and strengthening exercise of limbs, trunk stabilization training, wheelchair maneuver training and overground walking training. Based on this standard training program twice per week, 60 minutes per session, participants will receive an additional 30 minutes (exclude set-up time) of robotic-assisted body weight supported treadmill training (BWSTT) or control training based on their group allocation 3 times for 8 week. EMG biofeedback system will be applied to bilateral vastus lateralis muscles during training with audio feedback to promote active participation.
Outcome measures will be collected before the intervention and the subjects will be reassessed after finishing their 8 weeks of intervention. Outcome measures include Walking Index for Spinal Cord Injury version II, Spinal Cord Independence Measure version III, lower extremity motor score, Modified Ashworth Scale, L-stiff and L-force measured by Lokomat system, VO2 maximum, spirometry, and gait analysis (walking speed, heel-heel base support,bilateral stance duration, bilateral symmetry) The result of this study will provide useful information to enhance the clinical effectiveness of the management for spinal cord injury with the use of robotic assisted body weight supported treadmill training.
- Conditions
- Spinal Cord Injury
- Being tested
- Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland), Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)
- Keywords
- Spinal cord injury, robotic, locomotion
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)Device
Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)Device
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted body weight supported treadmill training | Active comparator | Robotic assisted body weight supported treadmill training with conventional PT training Receives: Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) |
| Passive lower limbs mobilization training | Placebo comparator | Passive lower limbs mobilization training with conventional PT training Receives: Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks
A validated mobility independence assessment tool for spinal cord injury (SCI) population (Burns, Delparte, Patrick, Marino, \& Ditunno, 2011). Subjects will be asked to walk on a 10-meter straight line and score will be given based on the use of walking aids, orthoses, manual assistance and distance covered.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
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 Spinal Cord InjuryStudies 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
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Mr. Cheung Yu Yeung, Kowloon Hospital, Hong Kong
- Investigators
- Cheung Yu Yeung E, BSc, Principal investigator, Kowloon Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989806
- Sponsor's protocol ID
- SCI-1
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2013
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheung EYY, Yu KKK, Kwan RLC, Ng CKM, Chau RMW, Cheing GLY. Effect of EMG-biofeedback robotic-assisted body weight supported treadmill training on walking ability and cardiopulmonary function on people with subacute spinal cord injuries - a randomized controlled trial. BMC Neurol. 2019 Jun 24;19(1):140. doi: 10.1186/s12883-019-1361-z.
PubMed 31234791
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Effect of Robotic-assisted Body Weight Supported Treadmill Training on Walking and Cardiopulmonary Recovery in Patients Suffering From Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01989806
- Acronym / sponsor ID
- SCI-1
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, robotic, locomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Nov 2013 (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.
Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and shorter life expectancy. Different modalities were developed aiming at mobility restoration in SCI patients and robotic assisted body weight supported treadmill training is one of the latest technique in recent years. Yet there are scarce studies to investigate its effectiveness. The purpose of this study is to investigate the effectiveness of robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary function of patients suffering from SCI by a randomized controlled trial.
80 patients suffering from incomplete SCI will be recruited for an 8-week training program. They will be randomized into either robotic assisted body weight supported treadmill training group or passive lower limb mobilization training group. The training effects will be measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score, lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under sub maximal exercise stress test.
Through the study, we intent to find the effectiveness of robotic-assisted body weight support treadmill training on walking and cardiopulmonary recovery with patients suffering from incomplete spinal cord injury.
The hypothesis of the study is:
Compared to the control group, robotic-assisted body weight supported treadmill training leads to a greater improvement in walking ability and cardiopulmonary functioning.
Detailed description
Participants will be recruited from the spinal cord rehabilitation unit of Physiotherapy Department of Kowloon Hospital. Subjects will be allocated into intervention group or control group by using sealed envelope and they will be blinded for their group allocation. All participants will undergo standard physiotherapy program, including mobilization and strengthening exercise of limbs, trunk stabilization training, wheelchair maneuver training and overground walking training. Based on this standard training program twice per week, 60 minutes per session, participants will receive an additional 30 minutes (exclude set-up time) of robotic-assisted body weight supported treadmill training (BWSTT) or control training based on their group allocation 3 times for 8 week. EMG biofeedback system will be applied to bilateral vastus lateralis muscles during training with audio feedback to promote active participation.
Outcome measures will be collected before the intervention and the subjects will be reassessed after finishing their 8 weeks of intervention. Outcome measures include Walking Index for Spinal Cord Injury version II, Spinal Cord Independence Measure version III, lower extremity motor score, Modified Ashworth Scale, L-stiff and L-force measured by Lokomat system, VO2 maximum, spirometry, and gait analysis (walking speed, heel-heel base support,bilateral stance duration, bilateral symmetry) The result of this study will provide useful information to enhance the clinical effectiveness of the management for spinal cord injury with the use of robotic assisted body weight supported treadmill training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted body weight supported treadmill training | Active comparator | Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)Robotic assisted body weight supported treadmill training with conventional PT training |
| Passive lower limbs mobilization training | Placebo comparator | Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)Passive lower limbs mobilization training with conventional PT training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patient with age 18 or above
- suffering from incomplete spinal cord injury with classification B, C or D under the International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI)
- lesion level above or at T12; acquired the injury not more than 24 months at the time of recruitment
- traumatic or non-traumatic, non-progressive lesion
- able to tolerate standing on tilt-table in 90 degrees for more than 30 minutes
Key exclusion criteria (7 listed)
- fracture of spine or lower limbs which is not yet stabilized
- severe osteoporosis or at high risk of pathological fracture
- symptomatic postural hypotension; cardiac disease which is not recommended for moderate intensity exercise
- severe muscle spasticity over lower limbs
- severe lower limbs fixed contractures
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 |
|---|---|---|
| Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) | Device | Robotic-assisted body weight supported treadmill training |
| Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) | Device | Passive lower limbs mobilization training |
Primary outcome
Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks
Time frame: Baseline, 8 weeks
A validated mobility independence assessment tool for spinal cord injury (SCI) population (Burns, Delparte, Patrick, Marino, \& Ditunno, 2011). Subjects will be asked to walk on a 10-meter straight line and score will be given based on the use of walking aids, orthoses, manual assistance and distance covered.
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 Jan 2019.
- Derived from this study: PubMed 31234791Cheung EYY, Yu KKK, Kwan RLC, Ng CKM, Chau RMW, Cheing GLY. Effect of EMG-biofeedback robotic-assisted body weight supported treadmill training on walking ability and cardiopulmonary function on people with subacute spinal cord injuries - a randomized controlled trial. BMC Neurol. 2019 Jun 24;19(1):140. doi: 10.1186/s12883-019-1361-z.
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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.
Cheung Yu Yeung E, BSc principal investigator
Kowloon Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) and Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) in people with Spinal Cord Injury, run by Kowloon Hospital, Hong Kong at 1 site in China.
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 6 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 28 Jan 2019. 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 China. 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. Some participants in this study may receive a placebo. 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?
Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks (time frame: Baseline, 8 weeks). 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 NCT01989806, 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 28 Jan 2019.