Trial Outcomes & Findings for Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients (NCT NCT03801473)

NCT ID: NCT03801473

Last Updated: 2021-05-07

Results Overview

Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: baseline
• Results posted on: 2021-05-07

Participant Flow

Participant milestones

Measure	Robot Assisted Gait robot assisted gait therapy: The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.	Conventional Rehabilitation Conventional rehabilitation: Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
Overall Study STARTED	21	21
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.	Total n=37 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 9.2 • n=18 Participants	44.7 years STANDARD_DEVIATION 8.4 • n=19 Participants	44.8 years STANDARD_DEVIATION 8.7 • n=37 Participants
Sex: Female, Male Female	11 Participants n=18 Participants	13 Participants n=19 Participants	24 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	6 Participants n=19 Participants	13 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Disease duration	14.1 years STANDARD_DEVIATION 5.9 • n=18 Participants	13.4 years STANDARD_DEVIATION 6.2 • n=19 Participants	13.7 years STANDARD_DEVIATION 6.0 • n=37 Participants

PRIMARY outcome

Timeframe: baseline

Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Fatigue Severity Score	5.5 score on a scale Interval 4.11 to 7.0	6 score on a scale Interval 4.11 to 7.0

PRIMARY outcome

Timeframe: after treatment (4th week)

Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Fatigue Severity Score	4.4 score on a scale Interval 3.0 to 6.44	5.8 score on a scale Interval 3.89 to 6.89

PRIMARY outcome

Timeframe: 3 months after treatment

Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Fatigue Severity Score	5.5 score on a scale Interval 3.33 to 7.0	5.7 score on a scale Interval 4.0 to 7.0

PRIMARY outcome

Timeframe: Baseline

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)	8.5 score on a scale Interval 0.0 to 12.0	10 score on a scale Interval 1.0 to 15.0

PRIMARY outcome

Timeframe: After treatment (4th week)

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)	5.5 score on a scale Interval 0.0 to 12.0	9 score on a scale Interval 1.0 to 15.0

PRIMARY outcome

Timeframe: 3 months after treatment

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)	6.5 score on a scale Interval 0.0 to 13.0	9 score on a scale Interval 1.0 to 16.0

PRIMARY outcome

Timeframe: baseline

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)	7.5 score on a scale Interval 3.0 to 13.0	8 score on a scale Interval 3.0 to 16.0

PRIMARY outcome

Timeframe: After treatment (4th week)

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)	5 score on a scale Interval 1.0 to 17.0	8 score on a scale Interval 3.0 to 15.0

PRIMARY outcome

Timeframe: 3 months after treatment

Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).

HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)	5 score on a scale Interval 2.0 to 15.0	8 score on a scale Interval 2.0 to 16.0

SECONDARY outcome

Timeframe: baseline

The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.

This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.

The summary scores are the physical health composite summary and the mental health composite summary.

Each composite summary scored 0-100. Higher values indicate better QoL.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health	28.5 score on a scale Interval 14.4 to 65.1	29.9 score on a scale Interval 10.8 to 63.1

SECONDARY outcome

Timeframe: after treatment (4th week)

The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.

This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.

The summary scores are the physical health composite summary and the mental health composite summary.

Each composite summary scored 0-100. Higher values indicate better QoL.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health	34.2 score on a scale Interval 16.7 to 70.8	33.7 score on a scale Interval 16.2 to 73.4

SECONDARY outcome

Timeframe: 3 months after treatment

The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.

This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.

The summary scores are the physical health composite summary and the mental health composite summary.

Each composite summary scored 0-100. Higher values indicate better QoL.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health	32.9 score on a scale Interval 17.1 to 70.8	29.1 score on a scale Interval 16.2 to 65.1

SECONDARY outcome

Timeframe: baseline

The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Expanded Disability Status Scale (EDSS)	6.5 units on a scale Interval 5.5 to 7.0	6 units on a scale Interval 5.5 to 7.0

SECONDARY outcome

Timeframe: after treatment (4th week)

The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Expanded Disability Status Scale (EDSS)	6 units on a scale Interval 5.5 to 7.0	6 units on a scale Interval 5.5 to 7.0

SECONDARY outcome

Timeframe: 3 months after treatment

The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Expanded Disability Status Scale (EDSS)	6 units on a scale Interval 5.0 to 7.0	6 units on a scale Interval 5.5 to 7.0

SECONDARY outcome

Timeframe: baseline

scored 0 to 5 (non functional ambulator to independant ambulator)

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Functional Ambulation Classification	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: after treatment (4th week)

scored 0 to 5 (non functional ambulator to independant ambulator)

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Functional Ambulation Classification	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 3 months after treatment

scored 0 to 5 (non functional ambulator to independant ambulator)

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Functional Ambulation Classification	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: baseline

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Walking Ability	50 meters Interval 0.0 to 200.0	60 meters Interval 1.0 to 200.0

SECONDARY outcome

Timeframe: after treatment (4th week)

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Walking Ability	70 meters Interval 1.0 to 210.0	70 meters Interval 5.0 to 240.0

SECONDARY outcome

Timeframe: 3 months after treatment

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Walking Ability	60 meters Interval 1.0 to 210.0	65 meters Interval 5.0 to 240.0

SECONDARY outcome

Timeframe: Baseline

Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Berg Balance Test (BBT)	20 score on a scale Interval 0.0 to 39.0	15 score on a scale Interval 5.0 to 49.0

SECONDARY outcome

Timeframe: After treatment (4th week)

Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Berg Balance Test (BBT)	24.5 score on a scale Interval 2.0 to 42.0	18 score on a scale Interval 8.0 to 50.0

SECONDARY outcome

Timeframe: 3 months after treatment

Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.

Outcome measures

Measure	Robot Assisted Training (RAT) n=18 Participants RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities	Conventional Training (CT) n=19 Participants Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
Berg Balance Test (BBT)	23 score on a scale Interval 2.0 to 40.0	18 score on a scale Interval 8.0 to 50.0

Adverse Events

Robot Assisted Training (RAT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Training (CT)

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

Tugba Ozsoy

Sultan Abdulhamid Han Training and Research Hospital

Phone: +902165422020

Email: tugbaozsoyy@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place