Clinical trial NCT01989806: Robotic-assisted Locomotor Training on Mobility and Cardiopulmonary Function in Patients Suffering From Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
robotic
locomotion
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2013-11-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
Secondary outcomes:
Other outcomes:
measure: Change in Spinal Cord Independence Measure version III from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in lower extremity motor score from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in Modified Ashworth Scale from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in L-force from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in walking quality from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in maximal oxygen consumption from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in L-stiff from baseline to 8 weeks
timeFrame: Baseline, 8 weeks
measure: Spirometry
timeFrame: Baseline, 8 weeks
Locations:
city: Hong Kong
country: China
facility: Physiotherapy Department, Kowloon Hospital
Study officials:
affiliation: Kowloon Hospital, Hong Kong
name: Cheung Yu Yeung E, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.