MotionTherapy@Home - baseline study for evaluation of safety and efficacy of a robotic locomotion training device for therapy at home
Organizational Data
- DRKS-ID:
- DRKS00005587
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2013-12-06
- Last update in DRKS:
- 2021-08-12
- Registration type:
- Retrospective
Acronym/abbreviation of the study
MotionTherapy@Home
URL of the study
No Entry
Brief summary in lay language
In recent years significant improvements of the locomotor capabilities of patients with incomplete spinal cord injury have been achieved with the application of special, large scale locomotion training robots. However, it seems that a long-term improvement of the walking function can only be maintained, if the training continues at home. With the current available, large scale technology of locmotion robots a long-term training is costly and hard to implement. It is therefore important that a cheap and portable locomotion robot for home use is available to continue the therapy. Most recent research results showed that the cyclic, gait-phase related stimulation and loading of the foot sole is relevant for a therapy success. The aim of this research project is the development of a modular and flexible concept with a minimum of technical complexity, which can be used at home, and the implementation of several prototypes of this machine. The aim of the pilot study is to test the safety and efficacy of these devices in terms of improvement of walking function in chronic, motor incomplete, partially ambulatory individuals with spinal cord injury.
Brief summary in scientific language
In this one-arm baseline study the safety and efficacy of a novel, based on recent neuroscientific knowledge about the possibilities for activation and enhancement of the pasticity of nerve structures in the central nervous system locomotion robot for at-home training will be tested. After 3 weekly baseline assessments of the walking capability (walking tests: 10m-Test, 6-Min.-Test, Timed-up-and-go-Test) and of the neurological status(ISNCSCI) and spasticity (modified Ashworth-Scale) 8-weeks of locmotion training will start with 5x per week with each session lasting for 45 Min.. Assessments will be performed at 4 weeks and 8 weeks after therapy onset. 3 months after end of therapy a follow-up assessment will be performed.
Health condition or problem studied
- Free text:
- motor incomplete, traumatic, chronic (> 1 year after trauma) spinal cord injured individuals
- ICD10:
- G82 - Paraplegia and tetraplegia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 5 therapy sessions per week each lasting 40 min. with the novel locomotion trainer. Overall therapy period of 8 weeks. Assessment of the gait capabilities before, directly after and 3 months after the therapy period.
Endpoints
- Primary outcome:
- The primary variables are the number of device related adverse events as marker of the safety of the device and tests for direct quantification of the walking capabilities i.e., changes in the 10 Meter Timed Walk Test, im Timed-up-and-go Test, in the 6.-Min. Walk Test and in the SCI Functional Abulation Inventory (SCI-FAI) between baseline and end of therapy.
- Secondary outcome:
- Sekondary variables are the motor and sensory ASIA (American Spinal Injury Association)-Scores for quatification of changes in the neurological status and the modifies Ashworth-Scale for classification of changes in the spasticity between baseline and theray end. Additionally, changes in the WISCI II, subjective patient reported changes in walking function and changes in quality of life (Münchner Lebensqualitäts-Dimensionen Liste - MLDL) are documented. By analyzing the status at a follow-up examination 3 months after end of therapy it will be possible to determine, if improvements will get lost after end of therapy or if they will continue after the therapy.
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Orthopädische Universitätsklinik Heidelberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2009-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2012-12-31
- Target Sample Size:
- 30
- Final Sample Size:
- 25
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional Inclusion Criteria:
- motor incomplete spinal cord injury; time after trauma between 1 and 5 years; age between 18 and 60; traumatic, haemorrhagic spinal cord injury or spinal cord injury after disc herniation; Walking Index for Spinal Cord Injury >= 5 (basic walking function)
Exclusion Criteria
body weight > 130kg; body height > 200cm; leg length discrepancy > 2 cm; moderate to severe contractures of hip, knee and ankle joints (> 20% of the normal range of motion); severe osteoporosis in the legs; instable fractures, open injuries or pressure sores at the trunk or lower extremities; extreme spasticity; cardiovascular, pulmonary, metabolic or additional orthopedic diseases that additionally restrict the walking function; severe depression; non-neglectable (> 15%) changes in baseline parameters (signs of neurological recovery); WISCI > 20 and one-leg stand possible for min. 3 sec bilaterally (already normal walking function)
Addresses
Primary Sponsor
- Address:
- Stiftung Orthopädische Universitätsklinik; Abteilung Orthopädie IIDr.-Ing. Rüdiger RuppSchlierbacher Landstr. 200a69118 HeidelbergGermany
- Telephone:
- 06221/ 562 9230
- Fax:
- 06221/ 562 9230
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Stiftung Orthopädische Universitätsklinik;Abteilung Orthopädie IIDr.-Ing. Rüdiger RuppSchlierbacher Landstr. 200a69118 HeidelbergGermany
- Telephone:
- 06221/ 562 9230
- Fax:
- 06221/ 562 9230
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Stiftung Orthopädische Universitätsklinik; Abteilung Orthopädie IIDr.-Ing. Rüdiger RuppSchlierbacher Landstr. 200a69118 HeidelbergGermany
- Telephone:
- 06221/ 562 9230
- Fax:
- 06221/ 562 9230
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Stiftung Orthopädische Universitätsklinik;Abteilung Orthopädie IIDr.-Ing. Rüdiger RuppSchlierbacher Landstr. 200a69118 HeidelbergGermany
- Telephone:
- 06221/ 562 9230
- Fax:
- 06221/ 562 9230
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2007-05-02
- Ethics committee number:
- MV-174/2007
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2007-07-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- Abstract of the study results
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Publizierte Studienergebnisse Rupp et al., PLOS One, 2015
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry