Trial Outcomes & Findings for G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis (NCT NCT03980145)
NCT ID: NCT03980145
Last Updated: 2022-02-14
Results Overview
Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)
Results posted on
2022-02-14
Participant Flow
Participant milestones
| Measure |
Conventional Physical Therapy
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has a unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=7 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 14.46 • n=8 Participants
|
52.5 years
STANDARD_DEVIATION 13.18 • n=15 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants
|
7 Participants
n=8 Participants
|
11 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
15 participants
n=15 Participants
|
|
Expanded Disability Status Scale (EDSS)
|
6.0 units on a scale
STANDARD_DEVIATION 0.33 • n=7 Participants
|
5.81 units on a scale
STANDARD_DEVIATION 0.88 • n=8 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 0.74 • n=15 Participants
|
PRIMARY outcome
Timeframe: Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Comfortable Walking Speed
Pretest Assessment (Prior to starting intervention training)
|
.45 meters per second
Standard Error .080
|
.60 meters per second
Standard Error .137
|
|
Comfortable Walking Speed
Posttest Assessment (After completing intervention training)
|
.52 meters per second
Standard Error 0.90
|
.67 meters per second
Standard Error .163
|
PRIMARY outcome
Timeframe: Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Two Minute Walk Test
Pretest Assessment (Prior to the start of intervention training)
|
66.57 Meters
Standard Error 10.90
|
89.35 Meters
Standard Error 21.38
|
|
Two Minute Walk Test
Posttest Assessment (Following completion of intervention training)
|
72.62 Meters
Standard Error 14.23
|
93.21 Meters
Standard Error 19.14
|
PRIMARY outcome
Timeframe: Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Modified Fatigue Impact Scale
Posttest Psychological Domain
|
4.0 score on a scale
Standard Error .535
|
2.88 score on a scale
Standard Error .766
|
|
Modified Fatigue Impact Scale
Posttest Total Score
|
40.71 score on a scale
Standard Error 5.20
|
34.25 score on a scale
Standard Error 4.87
|
|
Modified Fatigue Impact Scale
Pretest Physical Domain
|
23.71 score on a scale
Standard Error 3.74
|
25.88 score on a scale
Standard Error 1.74
|
|
Modified Fatigue Impact Scale
Pretest Total Score
|
50.14 score on a scale
Standard Error 4.93
|
43.75 score on a scale
Standard Error 4.61
|
|
Modified Fatigue Impact Scale
Posttest Physical Domain
|
24.57 score on a scale
Standard Error 1.55
|
19.50 score on a scale
Standard Error 2.33
|
|
Modified Fatigue Impact Scale
Pretest Cognitive Domain
|
20.43 score on a scale
Standard Error 1.78
|
14.37 score on a scale
Standard Error 4.04
|
|
Modified Fatigue Impact Scale
Posttest Cognitive Domain
|
12.14 score on a scale
Standard Error 2.86
|
11.88 score on a scale
Standard Error 3.54
|
|
Modified Fatigue Impact Scale
Pretest Psychological Domain
|
6.0 score on a scale
Standard Error .436
|
3.50 score on a scale
Standard Error .964
|
PRIMARY outcome
Timeframe: Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Multiple Sclerosis Impact Scale-29
Pretest Physical Subscale
|
65.89 units on a scale
Standard Error 4.26
|
47.97 units on a scale
Standard Error 7.97
|
|
Multiple Sclerosis Impact Scale-29
Posttest Physical Subscale
|
52.32 units on a scale
Standard Error 5.14
|
33.13 units on a scale
Standard Error 8.14
|
|
Multiple Sclerosis Impact Scale-29
Pretest Psychological Subscale
|
55.16 units on a scale
Standard Error 3.12
|
30.56 units on a scale
Standard Error 7.57
|
|
Multiple Sclerosis Impact Scale-29
Posttest Psychological Subscale
|
32.94 units on a scale
Standard Error 3.34
|
26.39 units on a scale
Standard Error 7.84
|
PRIMARY outcome
Timeframe: Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Fast Walking Speed
Pretest Assessment (Prior to intervention training)
|
.55 meters per second
Standard Error .108
|
.81 meters per second
Standard Error .190
|
|
Fast Walking Speed
Posttest Assessment (following completion of intervention training)
|
.63 meters per second
Standard Error .131
|
.84 meters per second
Standard Error .205
|
SECONDARY outcome
Timeframe: Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, \>14 is severe for both scales.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Pretest HADS Anxiety Score
|
8.43 score on a scale
Standard Error 1.445
|
5.88 score on a scale
Standard Error 1.076
|
|
Hospital Anxiety and Depression Scale (HADS)
Posttest HADS Anxiety Score
|
7.14 score on a scale
Standard Error 1.223
|
4.75 score on a scale
Standard Error 1.161
|
|
Hospital Anxiety and Depression Scale (HADS)
Pretest HADS Depression Score
|
7.57 score on a scale
Standard Error .869
|
4.75 score on a scale
Standard Error 1.187
|
|
Hospital Anxiety and Depression Scale (HADS)
Posttest HADS Depression Score
|
7.00 score on a scale
Standard Error .845
|
3.88 score on a scale
Standard Error 1.445
|
SECONDARY outcome
Timeframe: Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of "none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Short Form McGill Pain Questionnaire
Pretest Sensory Pain
|
10.14 score on a scale
Standard Error 2.80
|
5.00 score on a scale
Standard Error 2.62
|
|
Short Form McGill Pain Questionnaire
Posttest Sensory Pain
|
8.29 score on a scale
Standard Error 2.88
|
5.38 score on a scale
Standard Error 2.70
|
|
Short Form McGill Pain Questionnaire
Pretest Affective Pain
|
2.57 score on a scale
Standard Error .80
|
1.63 score on a scale
Standard Error .74
|
|
Short Form McGill Pain Questionnaire
Posttest Affective Pain
|
2.29 score on a scale
Standard Error 1.22
|
1.88 score on a scale
Standard Error 1.15
|
|
Short Form McGill Pain Questionnaire
Pretest Total Pain
|
12.71 score on a scale
Standard Error 4.057
|
6.63 score on a scale
Standard Error 2.890
|
|
Short Form McGill Pain Questionnaire
Posttest Total Pain
|
11.14 score on a scale
Standard Error 4.114
|
7.25 score on a scale
Standard Error 4.057
|
SECONDARY outcome
Timeframe: Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Late-Life Disability Inventory (LLFDI)
LLFDI Frequency Pretest
|
50.10 score on a scale
Standard Error 2.13
|
55.21 score on a scale
Standard Error 2.38
|
|
Late-Life Disability Inventory (LLFDI)
LLFDI Frequency Posttest
|
49.78 score on a scale
Standard Error 2.74
|
54.93 score on a scale
Standard Error 2.57
|
|
Late-Life Disability Inventory (LLFDI)
LLFDI Limitations Pretest
|
52.72 score on a scale
Standard Error 1.79
|
60.27 score on a scale
Standard Error 2.73
|
|
Late-Life Disability Inventory (LLFDI)
LLFDI Limitations Posttest
|
56.00 score on a scale
Standard Error 2.78
|
62.44 score on a scale
Standard Error 2.99
|
SECONDARY outcome
Timeframe: Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.
Outcome measures
| Measure |
Conventional Physical Therapy
n=7 Participants
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
|
End-Effector Robotic Training
n=8 Participants
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
|
|---|---|---|
|
Late-Life Function Inventory
LLDFI Function Pretest
|
43.65 score on a scale
Standard Error 1.51
|
45.76 score on a scale
Standard Error 2.96
|
|
Late-Life Function Inventory
LLFDI Function Posttest
|
48.13 score on a scale
Standard Error 2.70
|
53.27 score on a scale
Standard Error 3.24
|
Adverse Events
Conventional Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
End-Effector Robotic Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place