NCT03801473

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 2, 2021

Completed
Last Updated

May 7, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

January 9, 2019

Results QC Date

December 30, 2020

Last Update Submit

April 11, 2021

Conditions

Multiple Sclerosis

Keywords

rehabilitationrobot assisted gait training

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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)

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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)

  • 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 Outcomes (15)

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

    baseline

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

    after treatment (4th week)

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

    3 months after treatment

  • Expanded Disability Status Scale (EDSS)

    baseline

  • Expanded Disability Status Scale (EDSS)

    after treatment (4th week)

  • +10 more secondary outcomes

Study Arms (2)

robot assisted training (RAT)

EXPERIMENTAL

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

Other: robot assisted gait therapy

conventional training (CT)

ACTIVE COMPARATOR

Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.

Other: Conventional rehabilitation

Interventions

robot assisted gait therapyOTHER

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.

robot assisted training (RAT)
Conventional rehabilitationOTHER

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

conventional training (CT)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27762641BACKGROUND

  • 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.

    PMID: 28241776BACKGROUND

  • 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.

    PMID: 24904361BACKGROUND

  • Ozsoy-Unubol T, Ata E, Cavlak M, Demir S, Candan Z, Yilmaz F. Effects of Robot-Assisted Gait Training in Patients With Multiple Sclerosis: A Single-Blinded Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):768-774. doi: 10.1097/PHM.0000000000001913. Epub 2021 Oct 21.

    PMID: 34686632DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Tugba Ozsoy
Organization
Sultan Abdulhamid Han Training and Research Hospital
tugbaozsoyy@gmail.com
+902165422020

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

February 4, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 7, 2021

Results First Posted

February 2, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)