NCT03340792

Brief Summary

The present study aims to investigate the effects of ReWalk exoskeleton robot training on various physiological and psychological parameters among subjects with spinal cord injury, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life. Ten patients with paraplegia caused by spinal cord injury will be recruited from the out-patient clinic of Department of Physical Medicine and Rehabilitation at the China Medical University hospital. All participants will undergo dual X-ray absorptiometry to evaluate the baseline bone mineral density. Eligible participants will then take ReWalk training sessions comprises of 3 x 1-hour sessions per week for 40 sessions. A comprehensive battery of outcome measures, including body composition and bone mineral mass, balance ability, bowel and bladder symptoms, severity of pain, psychological well-being, and quality of life, will be utilized for comparison after 40 sessions of ReWalk ambulation training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

November 7, 2017

Last Update Submit

January 5, 2018

Conditions

Spinal Cord Injuries

Keywords

Exoskeleton DeviceRehabilitationBody compositionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    bone mineral density of the lumbar spine, the proximal femoral region and the distal forearms, measured by dual X-ray absorptiometry

    Change from baseline at 1 week after completion of 40 hours of ambulation training

Secondary Outcomes (5)

  • SF-36

    change from baseline at 1 week after completion of 40 hours of ambulation training

  • Spinal Cord Injury-Quality of Life measurement system

    change from baseline at 1 week after completion of 40 hours of ambulation training

  • fat mass

    change from baseline at 1 week after completion of ambulation training

  • lean body mass

    change from baseline at 1 week after completion of 40 hours of ambulation training

  • Berg Balance Scale

    change from baseline at 1 week after completion of 40 hours of ambulation training

Study Arms (1)

Exoskeleton robot ambulation training

EXPERIMENTAL

Ambulation training utilizing an exoskeleton robot

Device: Ambulation training utilizing an exoskeleton robot

Interventions

Ambulation training utilizing an exoskeleton robotDEVICE

Participants undergo 40 hours of ambulation training utilizing an exosksleton robot within 3 months.

Exoskeleton robot ambulation training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the age of 20-65 years old;
  • Have paraplegia resulting from thoracic or lumbar spinal cord injury.
  • At least 6 months after onset of the spinal cord injury
  • Well motivated and willing to participate 40 hours of ReWalk ambulation training sessions.

You may not qualify if:

  • Have spinal cord injury neurologic level above T4
  • Height greater than 190 cm or lower than160 cm
  • Weight greater than 100 kg
  • Have osteoporosis (T-score \< -2.5)
  • Deep vein thrombosis
  • Severe orthostatic hypotension precluding standing and walking training
  • Pregnancy
  • Cognitive impairments that would impact on the safe participation in the study
  • Severe spasticity of lower limbs (Modified Ashworth Scale \>3)
  • Contracture of the ankle, or a knee flexion contracture greater than 10 degrees
  • Musculoskeletal conditions that affected gait capacity
  • Co-existence of other neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospial

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nai-Hsin Meng, M.D.

    China Medical University, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nai-Hsin Meng, M.D.

CONTACT

886-4-22052121nsmeng@ms13.hinet.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 14, 2017

Study Start

November 23, 2017

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

TW(1)