|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| REWARD: REcovery of Walking Ability using a Robotic Device |
| ISRCTN | ISRCTN67827069 |
| DOI | 10.1186/ISRCTN67827069 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | REWARD: REcovery of Walking Ability using a Robotic Device |
| Scientific title | REWARD: REcovery of Walking Ability using a Robotic Device: a pre-test, post-test single group study |
| Acronym | REWARD |
| Serial number at source | N/A |
| Study hypothesis | We hypothesized that patients would significantly improve their walking ability, strength and cardiorespiratory fitness during the intervention period. |
| Lay summary |
Background and study aims
Approximately half of the population of patients with lesions (damage) of the spinal cord have a motor or sensory incomplete lesion (iSCI), meaning that there is still some muscle function or sensory function present in regions below the lesion level. Although the majority of the iSCI population regains some form of ambulation (walking) after rehabilitation, loss of strength and coordination substantially limit the ability to walk. The improvement of walking ability is an important goal during rehabilitation after an iSCI because even small gains in ambulation can make a meaningful amelioration (improvement) of a patient’s daily life. In the last decade, to relieve therapists and improve duration of therapy, therapy has been automated using robotic devices such as the Lokomat, a commercially available device. The goal of this initial study is to investigate whether walking speed and other gait related outcome measures improves during an intervention in which the Lokomat device is used. Who can participate? Patients were recruited from both the inpatient and outpatient clinic of a rehabilitation center in Amsterdam (Reade Rehabilitation and Rheumatology, Amsterdam). Patients were asked to participate in the study if they were older than 17 years, have overall good health and have a motor or sensory incomplete lesion. What does the study involve? Patients were treated on the LokomatPro device (Hocoma, Switzerland) for a total of 24 sessions. Three settings were manipulated during this study: speed, amount of body weight support (BWS) and the amount of assistance of the robotic orthoses, Guidance Force (GF). These settings were used so that the patients were still able to walk for about 20-45 minutes without getting tired/exhausted. The ultimate goal was to be to walk at high but still comfortable speed, with as little body weight support and guidance force as possible for as many minutes possible within the therapy time. The duration of the training sessions was 60 minutes, including preparation time. Before and after the intervention patients had several tests to asses walking ability, strength, fitness and balance. What are the possible benefits and risks of participating? Patients received an extra 24 sessions therapy in the Lokomat. Possible beneficial effects are improved walking ability, improved strength, improved fitness and improved bowel function. Information from this study will help to guide clinical recommendations on optimal therapy after incomplete spinal cord injury. By taking part in this study these patients may become fatigued (tired) by the training. Furthermore, there is a small risk on mild burns on the skin due to friction and possible discomfort from straps with which the body weight is supported during therapy. Where is the study run from? The study ran from Amsterdam Rehabilitation Research Centre When is the study starting and how long is it expected to run for? The study started in January 2009 and has ended in late 2012. Who is funding the study? Funding has been provided by Revalidatiefonds Who is the main contact? Prof. Dr. T.W.J. Janssen T.W.J.Janssen@vu.nl |
| Ethics approval | Centrale Commissie Mensgebonden Onderzoek (CCMO) VU University Medical Centre (NL22052.029.08) |
| Study design | Pre-test post-test single group design |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Incomplete Spinal Cord Injury |
| Participants - inclusion criteria | Patients, both male and female were asked to participate in the study if they were older than 17 years and had a motor or sensory incomplete lesion according to American Spinal Injury Association (ASIA) classification. |
| Participants - exclusion criteria |
1. Medical complications such as unstable hypertension, arrhythmias and unstable cardiovascular problems
2. Severe skeletal problems such as osteoarthritis or osteoporosis of the lower limbs |
| Anticipated start date | 01/01/2009 |
| Anticipated end date | 01/09/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions | Patients are treated on the Lokomat for a total of 24 sessions, with a frequency of twice a week (for 12 weeks). |
| Primary outcome measure(s) | Walking speed at the timed 10m walk test at baseline and after the intervention of 24 sessions after twelve weeks |
| Secondary outcome measure(s) |
1. Functional Ambulation Categories (FAC)
2. Berg Balance Scale (BBS) 3. Rivermead Mobility Index (RMI) 4. Hoffer classification (HOF) 5. Self-selected Walking Index for Spinal Cord Injury II (WISCI II) 6. Timed get-up and go test (TUG) 7. Cardiorespiratory outcome measures and isometric maximal knee extension and flexion strength Measured at baseline and after the intervention of 24 sessions after twelve weeks |
| Sources of funding | Rehabilitation Fund (Revalidatiefonds) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Prof Thomas W.J. Janssen |
| Address | Van der Boechorststraat 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1081BT |
| Country | Netherlands |
| T.W.J.Janssen@vu.nl | |
| Sponsor | Rehabilitation Fund (Revalidatiefonds) (Netherlands) |
| Address | J.F. Kennedylaan 99 |
| City/town | Bunnik |
| Zip/Postcode | 3981 GB |
| Country | Netherlands |
| secretariaat@fbw.vu.nl | |
| Sponsor website: | http://www.revalidatiefonds.nl/ |
| Date applied | 07/01/2013 |
| Last edited | 05/02/2013 |
| Date ISRCTN assigned | 05/02/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
