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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Kowloon Hospital, Hong Kong
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Mr. Cheung Yu Yeung, Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01989806
First received: November 8, 2013
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kowloon Hospital, Hong Kong:

Primary Outcome Measures:
  • Change in Walking Index for Spinal Cord Injury version II from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in Spinal Cord Independence Measure version III from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    A validated assessment tool for SCI patients (Catz et al., 2007) to measure performance in different aspects, including self-care ability, respiratory and sphincter management and mobility.. For self-care and respiratory & sphincter domain, scoring will be given based on patient's subjective report while the mobility performance will be tested by the assessors.

  • Change in lower extremity motor score from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    The sum of muscle power of the 5 key muscles of lower limb. Manual muscle testing will be adopted in testing the muscle power and the grading will be based on the Medical Research Council scale for muscle strength.

  • Change in Modified Ashworth Scale from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Hip and knee flexors and extensors will be tested. Subjects will be asked to relax during lying supine and assessor will passively move the limbs in fast speed. Scoring will be given based on the occurrence and quality of resistance.

  • Change in L-force from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Strength will be assessed by L-force function which is installed in Lokomat system. subjects will be asked to perform isometric muscle contraction of hips and knees, the sensors in orthoses will measure the force exerted on it and record the result.

  • Change in walking quality from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Walking speed, heel-heel base of support, bilateral legs stance duration and bilateral symmetry will be assessed by gait analysis system (GAITRite System, CIR Systems, Inc., US) . Subjects will be asked to walk on a pressure-detectable walkway, which is connected to a computer system. Assistance as well as orthoses will be provided based on subject's own choice. Two meters of acceleration distance will be provided before the subject walk onto the walkway while another two meters of deceleration distance will be provided so as to ensure that subjects walk with their fastest comfortable speed on the whole track of walkway. Bilateral symmetry will be assessed by the stride length ratio as well as stance phase duration ratio of the weak limb to strong limb, where the strong limb is defined as the one with higher score in lower extremity motor score.

  • Change in maximal oxygen consumption from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    For cardiopulmonary functioning, the subject will be asked to perform upper limb ergometry (Endorphin's 300 e2 resistance system, Endorphin Corporation, US) with a gas analysis system (Fitmate pro, COSMED, Italy). Subjects will wear a mask connecting to the gas analysis system and they will be asked to perform the upper limb ergometry with the following protocol: 1 minute of rest following with 1 minute of warm-up using the least resistance, then the resistance will be increased by 1 level per 1 minute time. The test will be stopped when the heart rate reaches 85% of maximal heart rate, or the subject cannot further tolerate the test. Maximal oxygen consumption will be recorded for further analysis.

  • Change in L-stiff from baseline to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Stiffness will be assessed by L-stiff function, which subjects will be asked to keep relaxing on the system while the Lokomat system performs passive limbs movement at different speed. The torque during movement will be detected by the sensors in the orthoses and recorded the result.

  • Spirometry [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Spirometry will be used to assess the respiratory function of subjects. Subjects will be asked to perform a forced and prolonged expiration via mouth piece which connecting to a spirometer (Pony FX, COSMED, Italy) followed with a forced inspiration. A soft clip will be applied to subject's nose to minimize air leak from nose during test. Peak expiratory flow (PEF), forced expiratory flow rate in first second (FEV1) and forced vital capacity (FVC) will be assessed. 3 trials will be performed with 1 minute rest interval to prevent hyperventilation and the average value of the 3 trials will be recorded for analysis.


Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Robotic-assisted body weight supported treadmill training
Robotic assisted body weight supported treadmill training with conventional PT training
Device: Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)
Placebo Comparator: Passive lower limbs mobilization training
Passive lower limbs mobilization training with conventional PT training
Device: Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989806

Contacts
Contact: Cheung Yu Yeung E, BSc 852-31297135 cyy477@ha.org.hk
Contact: Chau Mei Wa R, DHSc 852-31297123 chaumw@ha.org.hk

Locations
China
Physiotherapy Department, Kowloon Hospital Recruiting
Hong Kong, China
Contact: Chau Mei Wa R, DHSc    852-31297123    chaumw@ha.org.hk   
Principal Investigator: Cheung Yu Yeung E, BSc         
Sub-Investigator: Chau Mei Wa R, DHSc         
Sponsors and Collaborators
Kowloon Hospital, Hong Kong
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Cheung Yu Yeung E, BSc Kowloon Hospital, Hong Kong
  More Information

No publications provided

Responsible Party: Mr. Cheung Yu Yeung, Physiotherapist II, Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01989806     History of Changes
Other Study ID Numbers: SCI-1
Study First Received: November 8, 2013
Last Updated: August 10, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Kowloon Hospital, Hong Kong:
Spinal cord injury
robotic
locomotion

Additional relevant MeSH terms:
Spinal Cord Injuries
Stress, Psychological
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014