Spinal Cord Injury
Conditions
Keywords
ASIA C and D
Brief summary
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.
Detailed description
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.
Interventions
DEVICERAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
OTHERStrength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Time since lesion \> 1 year * Outdoor mobility SCIM III \< 5 * Stable walking capacity
Exclusion criteria
* participating on other training studies * osteoporosis * psychiatric diseases * epilepsia * body weight \> 130 kg * cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10 Meter Walking at Preferred Speed | Baseline, after intervention (4 weeks) | 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. |
| 10 Meter Walking at Maximal Speed | Baseline, after intervention (4 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure III | Baseline, after intervention (4 weeks) | 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. |
| Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | Baseline, after intervention (4 weeks) | 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. |
| Manual Muscle Test of the Lower Extremity | Baseline, after intervention (4 weeks) | 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. |
| Walking Index for Spinal Cord Injury II | Baseline, after intervention (4 weeks) | 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. |
| Response Time of the Lower Extremities | Baseline, after intervention (4 weeks) | 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. |
| Falls Efficacy Scale | Baseline, after intervention (4 weeks) | 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. |
| Figure of Eight Test | Baseline, after intervention (4 weeks) | 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. |
| Pain on a Visual Analogue Scale | Baseline, after intervention (4 weeks) | 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. |
| Berg Balance Scale | Baseline, after intervention (4 weeks) | 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. |
Countries
Switzerland
Participant flow
Recruitment details
Participant recruitment from a spinal cord injury hospital in Zurich, Switzerland between March 2009 and March 2011.
Pre-assignment details
97 possible participants recruited; 9 participated, 88 excluded (12 did not meet inclusion criteria and 76 refused participation)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Robot-assisted Gait Training First, Then Strength Training | Strength Training First, Then Robot-assisted Gait Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age Continuous | 58.8 years STANDARD_DEVIATION 11.1 | 59.3 years STANDARD_DEVIATION 12.8 | 59.0 years STANDARD_DEVIATION 11.1 |
| Height | 1.76 m STANDARD_DEVIATION 0.077 | 1.67 m STANDARD_DEVIATION 0.075 | 1.72 m STANDARD_DEVIATION 0.086 |
| Region of Enrollment Germany | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Switzerland | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
| Weight | 80.8 kg STANDARD_DEVIATION 15.9 | 70.0 kg STANDARD_DEVIATION 17.1 | 76.0 kg STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | 10 Meter Walking at Maximal Speed | 0.01 meters per second | Standard Deviation 0.18 |
| Strength Training | 10 Meter Walking at Maximal Speed | 0.14 meters per second | Standard Deviation 0.12 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | 10 Meter Walking at Preferred Speed | 0.04 meters per second | Standard Deviation 0.1 |
| Strength Training | 10 Meter Walking at Preferred Speed | 0.06 meters per second | Standard Deviation 0.08 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Berg Balance Scale | 1.11 units on a scale | Standard Deviation 1.9 |
| Strength Training | Berg Balance Scale | 2.78 units on a scale | Standard Deviation 1.92 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Falls Efficacy Scale | 0.17 units on a scale | Standard Deviation 4.99 |
| Strength Training | Falls Efficacy Scale | 0.56 units on a scale | Standard Deviation 2.88 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Figure of Eight Test | 0.004 meters per second | Standard Deviation 0.04 |
| Strength Training | Figure of Eight Test | 0.04 meters per second | Standard Deviation 0.09 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Manual Muscle Test of the Lower Extremity | 0.67 units on a scale | Standard Deviation 1.12 |
| Strength Training | Manual Muscle Test of the Lower Extremity | 1.00 units on a scale | Standard Deviation 1 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | 0.43 milliseconds | Standard Deviation 1.42 |
| Strength Training | Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis | 0.42 milliseconds | Standard Deviation 1.38 |
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.
Time frame: Baseline, after intervention (4 weeks)
Population: Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Pain on a Visual Analogue Scale | -4.5 units on a scale | Standard Deviation 2.2 |
| Strength Training | Pain on a Visual Analogue Scale | -6.8 units on a scale | Standard Deviation 2.5 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Response Time of the Lower Extremities | -1.8 milliseconds | Standard Deviation 63 |
| Strength Training | Response Time of the Lower Extremities | -17.6 milliseconds | Standard Deviation 66.4 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Spinal Cord Independence Measure III | 0.78 units on a scale | Standard Deviation 2.17 |
| Strength Training | Spinal Cord Independence Measure III | 1.33 units on a scale | Standard Deviation 1.87 |
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.
Time frame: Baseline, after intervention (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robot-assisted Gait Training | Walking Index for Spinal Cord Injury II | 0.78 units on a scale | Standard Deviation 1.6 |
| Strength Training | Walking Index for Spinal Cord Injury II | 0.33 units on a scale | Standard Deviation 1 |