Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CLI006/2 extension | Other Grant/Funding Number | Spinal Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.
Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First RAGT, then strength training | Experimental | 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period. |
|
| First strength training, then RAGT | Experimental | 16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAGT | Device | 16 sessions / 4 times/week / 45 minutes Lokomat training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walking at Preferred Speed | The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
| 10 Meter Walking at Maximal Speed | The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Index for Spinal Cord Injury II | The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huub van Hedel, PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | Canton of Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24401143 | Derived | Labruyere R, van Hedel HJ. Strength training versus robot-assisted gait training after incomplete spinal cord injury: a randomized pilot study in patients depending on walking assistance. J Neuroeng Rehabil. 2014 Jan 9;11:4. doi: 10.1186/1743-0003-11-4. |
Not provided
Not provided
97 possible participants recruited; 9 participated, 88 excluded (12 did not meet inclusion criteria and 76 refused participation)
Participant recruitment from a spinal cord injury hospital in Zurich, Switzerland between March 2009 and March 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Robot-assisted Gait Training First, Then Strength Training | 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period. |
| FG001 | Strength Training First, Then Robot-assisted Gait Training | 16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Robot-assisted Gait Training First, Then Strength Training | 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period. |
| BG001 | Strength Training First, Then Robot-assisted Gait Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 10 Meter Walking at Preferred Speed | The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | meters per second | Baseline, after intervention (4 weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot-assisted Gait Training First, Then Strength Training | 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period. |
Not provided
Not provided
Issues to find participants led to small numbers of subjects analyzed. Ambulatory activity besides our interventions was not controlled for.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hubertus van Hedel, PhD | UZurich | +41 44 762 52 91 | hubertus.vanhedel@kispi.uzh.ch |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Strength Training | Other | 16 sessions / 4 times/week / 45 minutes lower extremity strength training |
|
| Baseline, after intervention (4 weeks) |
| Berg Balance Scale | The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
| Spinal Cord Independence Measure III | The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
| Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) |
| Manual Muscle Test of the Lower Extremity | With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
| Pain on a Visual Analogue Scale | Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) |
| Response Time of the Lower Extremities | We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) |
| Falls Efficacy Scale | The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Baseline, after intervention (4 weeks) |
| Figure of Eight Test | The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Baseline, after intervention (4 weeks) |
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | m |
|
|
|
| Secondary | Walking Index for Spinal Cord Injury II | The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Berg Balance Scale | The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Spinal Cord Independence Measure III | The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Posted | Mean | Standard Deviation | milliseconds | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Manual Muscle Test of the Lower Extremity | With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Pain on a Visual Analogue Scale | Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Only 8 patients participated at pain assessments as 1 patient did not suffer from pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Response Time of the Lower Extremities | We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Posted | Mean | Standard Deviation | milliseconds | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Falls Efficacy Scale | The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after intervention (4 weeks) |
|
|
|
| Primary | 10 Meter Walking at Maximal Speed | The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | meters per second | Baseline, after intervention (4 weeks) |
|
|
|
| Secondary | Figure of Eight Test | The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements. | Posted | Mean | Standard Deviation | meters per second | Baseline, after intervention (4 weeks) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Strength Training First, Then Robot-assisted Gait Training | 16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period. | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |