Robotic-assisted Locomotor Training on Mobility and Cardiopulmonary Function in Patients Suffering From Spinal Cord Injury

NCT01989806 | Completed

• 1 other identifier: SCI-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Evidences showed that patients suffering from spinal cord injury (SCI) have poor mobility and higher chance to develop cardiopulmonary diseases, which leads to poor quality of life and shorter life expectancy. Different modalities were developed aiming at mobility restoration in SCI patients and robotic assisted body weight supported treadmill training is one of the latest technique in recent years. Yet there are scarce studies to investigate its effectiveness. The purpose of this study is to investigate the effectiveness of robotic-assisted body weight supported treadmill training on mobility and cardiopulmonary function of patients suffering from SCI by a randomized controlled trial. 80 patients suffering from incomplete SCI will be recruited for an 8-week training program. They will be randomized into either robotic assisted body weight supported treadmill training group or passive lower limb mobilization training group. The training effects will be measured by Walking Index for Spinal Cord Injury version II, lower extremity motor score, lower limb Modified Ashworth Scale, robotic gait system, gait analysis and gas analysis under sub maximal exercise stress test. Through the study, we intent to find the effectiveness of robotic-assisted body weight support treadmill training on walking and cardiopulmonary recovery with patients suffering from incomplete spinal cord injury. The hypothesis of the study is: Compared to the control group, robotic-assisted body weight supported treadmill training leads to a greater improvement in walking ability and cardiopulmonary functioning.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; robotic; locomotion

Outcome Measures

Primary Outcomes (1)

• Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks

  A validated mobility independence assessment tool for spinal cord injury (SCI) population (Burns, Delparte, Patrick, Marino, \& Ditunno, 2011). Subjects will be asked to walk on a 10-meter straight line and score will be given based on the use of walking aids, orthoses, manual assistance and distance covered.

  Baseline, 8 weeks

Other Outcomes (8)

• Change in Spinal Cord Independence Measure version III from baseline to 8 weeks

  Baseline, 8 weeks

• Change in lower extremity motor score from baseline to 8 weeks

  Baseline, 8 weeks

• Change in Modified Ashworth Scale from baseline to 8 weeks

  Baseline, 8 weeks

Study Arms (2)

Robotic-assisted body weight supported treadmill training

ACTIVE COMPARATOR

Robotic assisted body weight supported treadmill training with conventional PT training

Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)

Passive lower limbs mobilization training

PLACEBO COMPARATOR

Passive lower limbs mobilization training with conventional PT training

Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)

Interventions

Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland) DEVICE

Robotic-assisted body weight supported treadmill training

Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany) DEVICE

Passive lower limbs mobilization training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient with age 18 or above
• suffering from incomplete spinal cord injury with classification B, C or D under the International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI)
• lesion level above or at T12; acquired the injury not more than 24 months at the time of recruitment
• traumatic or non-traumatic, non-progressive lesion
• able to tolerate standing on tilt-table in 90 degrees for more than 30 minutes
• able to walk with or without orthosis but requires manual assistance in walking.

You may not qualify if:

• fracture of spine or lower limbs which is not yet stabilized
• severe osteoporosis or at high risk of pathological fracture
• symptomatic postural hypotension; cardiac disease which is not recommended for moderate intensity exercise
• severe muscle spasticity over lower limbs
• severe lower limbs fixed contractures
• leg length discrepancy for more than 2 centimeters
• body weight exceeding 135 kilograms

Sponsors & Collaborators

• Kowloon Hospital, Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Physiotherapy Department, Kowloon Hospital

Hong Kong, China

Location

Related Publications (1)

• Cheung EYY, Yu KKK, Kwan RLC, Ng CKM, Chau RMW, Cheing GLY. Effect of EMG-biofeedback robotic-assisted body weight supported treadmill training on walking ability and cardiopulmonary function on people with subacute spinal cord injuries - a randomized controlled trial. BMC Neurol. 2019 Jun 24;19(1):140. doi: 10.1186/s12883-019-1361-z.

  PMID: 31234791 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cheung Yu Yeung E, BSc

  Kowloon Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist II

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 21, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

CN (1)