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

NCT ID: NCT01989806

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

Participants will be recruited from the spinal cord rehabilitation unit of Physiotherapy Department of Kowloon Hospital. Subjects will be allocated into intervention group or control group by using sealed envelope and they will be blinded for their group allocation. All participants will undergo standard physiotherapy program, including mobilization and strengthening exercise of limbs, trunk stabilization training, wheelchair maneuver training and overground walking training. Based on this standard training program twice per week, 60 minutes per session, participants will receive an additional 30 minutes (exclude set-up time) of robotic-assisted body weight supported treadmill training (BWSTT) or control training based on their group allocation 3 times for 8 week. EMG biofeedback system will be applied to bilateral vastus lateralis muscles during training with audio feedback to promote active participation.

Outcome measures will be collected before the intervention and the subjects will be reassessed after finishing their 8 weeks of intervention. Outcome measures include Walking Index for Spinal Cord Injury version II, Spinal Cord Independence Measure version III, lower extremity motor score, Modified Ashworth Scale, L-stiff and L-force measured by Lokomat system, VO2 maximum, spirometry, and gait analysis (walking speed, heel-heel base support,bilateral stance duration, bilateral symmetry) The result of this study will provide useful information to enhance the clinical effectiveness of the management for spinal cord injury with the use of robotic assisted body weight supported treadmill training.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic-assisted body weight supported treadmill training

Robotic assisted body weight supported treadmill training with conventional PT training

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Passive lower limbs mobilization training

Passive lower limbs mobilization training with conventional PT training

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

Kowloon Hospital, Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Mr. Cheung Yu Yeung

Physiotherapist II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheung Yu Yeung E, BSc

Role: PRINCIPAL_INVESTIGATOR

Kowloon Hospital, Hong Kong

Locations

Physiotherapy Department, Kowloon Hospital

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31234791 (View on PubMed)

Other Identifiers

SCI-1

Identifier Type: -

Identifier Source: org_study_id