Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801473
• Other study ID #: Tugba Ozsoy
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2021
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.

Description:

Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training with robot assisted technology is used for rehabilitation. In several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. In this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years old Multiple Sclerosis patients
• EDSS score: 5.5-7.5
• Being oriented and cooperated
• Mini-mental score =24/30

Exclusion Criteria:

• Modified Ashworth >3 in lower extremity muscles
• Cognitive impairment
• Botox injection within last 6-months
• Having another neurological disease
• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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 program. Exercise and walking education is performed by the physiotherapists.

Locations

Country	Name	City	State
Turkey	Sultan Abdulhamid Han Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014. — View Citation

Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20. Review. — View Citation

Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Score	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.	baseline
Primary	Fatigue Severity Score	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.	after treatment (4th week)
Primary	Fatigue Severity Score	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.	3 months after treatment
Primary	Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)	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.	Baseline
Primary	Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)	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.	After treatment (4th week)
Primary	Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)	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.	3 months after treatment
Primary	Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)	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.	baseline
Primary	Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)	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.	After treatment (4th week)
Primary	Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)	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.	3 months after treatment
Secondary	Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health	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.	baseline
Secondary	Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health	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.	after treatment (4th week)
Secondary	Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health	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.	3 months after treatment
Secondary	Expanded Disability Status Scale (EDSS)	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.	baseline
Secondary	Expanded Disability Status Scale (EDSS)	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.	after treatment (4th week)
Secondary	Expanded Disability Status Scale (EDSS)	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.	3 months after treatment
Secondary	Functional Ambulation Classification	scored 0 to 5 (non functional ambulator to independant ambulator)	baseline
Secondary	Functional Ambulation Classification	scored 0 to 5 (non functional ambulator to independant ambulator)	after treatment (4th week)
Secondary	Functional Ambulation Classification	scored 0 to 5 (non functional ambulator to independant ambulator)	3 months after treatment
Secondary	Walking Ability	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.	baseline
Secondary	Walking Ability	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.	after treatment (4th week)
Secondary	Walking Ability	The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.	3 months after treatment
Secondary	Berg Balance Test (BBT)	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.	Baseline
Secondary	Berg Balance Test (BBT)	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.	After treatment (4th week)
Secondary	Berg Balance Test (BBT)	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.	3 months after treatment