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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation on the Effect of Robotic-assisted Body Weight Supported Treadmill Training on Walking and Cardiopulmonary Recovery in Patients Suffering From Incomplete Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)
* Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-assisted body weight supported treadmill training<br>Robotic assisted body weight supported treadmill training with conventional PT training | Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)<br> <br> |
| Placebo Comparator: Passive lower limbs mobilization training<br>Passive lower limbs mobilization training with conventional PT training | Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, robotic, locomotion