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Trial record 68 of 10364 for:    strength

Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01087918
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : October 19, 2012
Last Update Posted : October 29, 2012
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Spinal Cord Injury
Interventions Device: RAGT
Other: Strength Training
Enrollment 9
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)
Arm/Group Title Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
2
  50.0%
5
  55.6%
>=65 years
2
  40.0%
2
  50.0%
4
  44.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
58.8  (11.1) 59.3  (12.8) 59.0  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
1
  20.0%
3
  75.0%
4
  44.4%
Male
4
  80.0%
1
  25.0%
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Switzerland 4 3 7
Germany 1 1 2
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 5 participants 4 participants 9 participants
80.8  (15.9) 70.0  (17.1) 76.0  (16.4)
Height  
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 5 participants 4 participants 9 participants
1.76  (0.077) 1.67  (0.075) 1.72  (0.086)
1.Primary Outcome
Title 10 Meter Walking at Preferred Speed
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: meters per second
0.04  (0.10) 0.06  (0.08)
2.Primary Outcome
Title 10 Meter Walking at Maximal Speed
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First RAGT, Then Strength Training First Strength Training, Then RAGT
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: meters per second
0.01  (0.18) 0.14  (0.12)
3.Secondary Outcome
Title Walking Index for Spinal Cord Injury II
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.78  (1.6) 0.33  (1.0)
4.Secondary Outcome
Title Berg Balance Scale
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week
16 sessions of 45 minutes of strength training 4 times a week
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.11  (1.90) 2.78  (1.92)
5.Secondary Outcome
Title Spinal Cord Independence Measure III
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.78  (2.17) 1.33  (1.87)
6.Secondary Outcome
Title Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: milliseconds
0.43  (1.42) 0.42  (1.38)
7.Secondary Outcome
Title Manual Muscle Test of the Lower Extremity
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (1.12) 1.00  (1.00)
8.Secondary Outcome
Title Pain on a Visual Analogue Scale
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.5  (2.2) -6.8  (2.5)
9.Secondary Outcome
Title Response Time of the Lower Extremities
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: milliseconds
-1.8  (63.0) -17.6  (66.4)
10.Secondary Outcome
Title Falls Efficacy Scale
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.17  (4.99) 0.56  (2.88)
11.Secondary Outcome
Title Figure of Eight Test
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-assisted Gait Training Strength Training
Hide Arm/Group Description:
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: meters per second
0.004  (0.04) 0.04  (0.09)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Robot-assisted Gait Training First, Then Strength Training Strength Training First, Then Robot-assisted Gait Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%) 
Issues to find participants led to small numbers of subjects analyzed. Ambulatory activity besides our interventions was not controlled for.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hubertus van Hedel, PhD
Organization: UZurich
Phone: +41 44 762 52 91
EMail: hubertus.vanhedel@kispi.uzh.ch
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01087918     History of Changes
Other Study ID Numbers: EK-21/2008
CLI006/2 extension ( Other Grant/Funding Number: Spinal Research )
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: May 10, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 29, 2012