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Completed

NCT Number: NCT03801473

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robot assisted gait therapy

Other

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

Other

Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.

Primary outcomes

  1. Fatigue Severity Score

    Time frame: 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.

  2. Fatigue Severity Score

    Time frame: 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.

  3. Fatigue Severity Score

    Time frame: 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.

  4. Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)

    Time frame: 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.

  5. Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)

    Time frame: 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.

  6. Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)

    Time frame: 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.

  7. Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)

    Time frame: 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.

  8. Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)

    Time frame: 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.

  9. Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)

    Time frame: 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.

Secondary outcomes

  1. Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health

    Time frame: 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.

  2. Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health

    Time frame: 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.

  3. Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health

    Time frame: 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.

  4. Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  5. Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  6. Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  7. Functional Ambulation Classification

    Time frame: baseline

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

  8. Functional Ambulation Classification

    Time frame: after treatment (4th week)

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

  9. Functional Ambulation Classification

    Time frame: 3 months after treatment

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

  10. Walking Ability

    Time frame: 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.

  11. Walking Ability

    Time frame: 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.

  12. Walking Ability

    Time frame: 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.

  13. Berg Balance Test (BBT)

    Time frame: 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.

  14. Berg Balance Test (BBT)

    Time frame: 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.

  15. Berg Balance Test (BBT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2019
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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