Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001647143 Date of Approval: 21/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of a robotic walking intervention on individuals with spinal cord injury
Official scientific title The effect of robotic exoskeleton gait rehabilitation on individuals with chronic spinal cord injury
Brief summary describing the background and objectives of the trial At present, chronic out-patient rehabilitation does not fall within the standard of care within the South African context. With a deficiency in outpatient rehabilitation, many patients never reach the full potential of their functional capacity. Many remain wheel chair bound with minimal levels of physical activity. There is a need to develop the infrastructure and knowledge in South Africa to adequately provide for the long-term needs of all individuals with spinal cord injury, focusing on innovative rehabilitation that is targeted to strengthen and improve 1) psychological well being; 2) neuromuscular system and 3) functional capacity. The aim of this study is to evaluate the efficacy of robotic locomotor training (RLT) compared to activity based training (ABT) during a 24-week rehabilitation program in individuals with SCI. The study aims to measure the 1) neuromuscular effects 2) psychological well-being and 3) prevention of secondary complications in individuals with spinal cord injury when exposed to 24 weeks of RLT or ABT. The inclusion of all three aforementioned aims is a first within this field of research and will provide a comprehensive understanding of each participant passing through the rehabilitation programme.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Spinal Cord Injury
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 18/07/2016
Actual trial start date
Anticipated date of last follow up 04/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Upon completion of pre-screening, participants will be randomly assigned to the RLT or ABT groups via random number generation using Microsoft Excel. A number between 0 and 9 will be randomly generated for each participant. If the number generated falls within 0-4 then the participant will be allocated to the ABT group; if the number falls within 5-9 then the participant will be allocated to the RLT group. Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Upon completion of pre-screening, participants will be randomly assigned to the RLT or ABT groups via random number generation using Microsoft Excel. A number between 0 and 9 will be randomly generated for each participant. If the number generated falls within 0-4 then the participant will be allocated to the ABT group; if the number falls within 5-9 then the participant will be allocated to the RLT group. Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Robotic Locomotor Training 3 times per week 24 weeks Locomotor training will exclusively take part in the Ekso bionic walking suit. Participants will walk 3 times per week, allowing for sufficient rest between sessions. Each session will be a maximum of 45 minutes long. The intensity of the sessions will vary between participants and as the participant adapts through the program. 24
Control Group Activity Based Training 3 times per week 24 weeks The activity-based training (ABT) represents the current standard of care provided in advanced neurological rehabilitation centres around the world, such as the Shepherd Centre, USA . It involves a combination of standing, strength, flexibility and cardiovascular training. 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Male or female individuals with a SCI (traumatic) ¿ 18 through to 65 years old ¿ English speaking (Does not need to be 1st language but must be fluent) ¿ Chronic (>1yr) spinal cord injury ¿ Motor/Sensory incomplete (AIS B, C, D), with a neurological level of injury (NLI) between C1-C8 as determined by the International Standards for Neurological Classification of SCI (ISNCSCI) ¿ Reliant upon a wheelchair as their primary mode of mobility ¿ Sufficient anthropometrics and range of motion (ROM) to achieve a normal, reciprocal gait pattern within the EksoTM suit o Standing height: 157cm ¿ 188cm o Maximum hip width: 42cm o Upper leg length (Femur): 51cm to 61.4cm o Lower Leg length (Tibia): 48cm to 63.4cm o Maximum weight: 100 kilograms o Hip extension greater than or equal to 5 degrees o Knee extension less than or equal to 12 degrees o Ankle dorsiflexion greater than or equal to 0 degrees ¿ Sufficient upper extremity (UE) strength to use a front wheeled walker (FWW) either by manual muscle testing (MMT) (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) and/or by functional standing test with FWW. Participants with impaired hand function may use cuff grips. ¿ Demonstrate adequate trunk stability and upper extremity strength to utilize EksoTM bionic walking suit as evidenced by the ability to complete a level (or near level) surface wheelchair to mat transfer with minimal assistance. ¿ Medically stable and cleared by a physician for full weight bearing locomotor training including 15 minute standing frame trial to assess standing tolerance. ¿ Severe osteoporosis: DEXA Z score < -2 of the hip or lumbar spine ¿ Non-traumatic SCI ¿ Have trained in a robotic exoskeleton in the past ¿ Performing any other form of locomotor training ¿ Clinically Depressed (Beck Depression Inventory) ¿ Any medical issue that in the opinion of the investigator precludes full weight bearing locomotor training including but not limited to: o Heart or respiratory comorbidity o Spinal instability (or spinal orthotic unless cleared by physician) o Acute deep vein thrombosis (DVT) with activity restrictions o Stoma bag o Severe, recurrent autonomic dysreflexia (AD) requiring medical intervention o Heterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees o Two or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity o Hip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age. ¿ Any medical issue that in the opinion of the investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors ¿ Any issue that in the opinion of the investigator would confound results such as a concurrent neurological injury or disorder (other than SCI) ¿ Modified Ashworth Scale (MAS) = 4 in any of the lower extremity joints (i.e scored a 4 on the scale (indicating rigidity in the joint) when testing joint movements in lower extremities (hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion) ¿ Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting ¿ Pregnancy ¿ Z scores outside of recommended range (<-2) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/05/2016 UCT Faculty of Health Sciences Human Research Ethics Committee (HREC)
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Old Main Building, Groote Schuur Hospital, Observatory, 7925 Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2016 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2016 UCT Faculty of Health Sciences Human Research Ethics Committee (HREC)
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Old Main Building, Groote Schuur Hospital, Observatory, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neuromuscular Changes Baseline 12 Weeks 24 Weeks
Primary Outcome Psychological Changes Baseline and every 4 weeks up to 24 weeks
Primary Outcome Secondary Complications Baseline 12 Weeks 24 Weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sport Science Institute of South Africa 1 Boundary Road, Newlands Cape Town 7725 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation 1 Meiring Naude Rd Pretoria 0081 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Stellenbosch University Francie Van Zijl Drive, Tygerberg Hospital Cape Town 7505 South Africa
Cape Peninsula University of Technology Symphony Way, Bellville Cape Town 7535 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yumna Albertus yumna.albertus@uct.ac.za +27 (0)21 6504560 1 Boundary Road, Newlands
City Postal code Country Position/Affiliation
Cape Town 7725 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Robert Evans robertevanssa@gmail.com 0729852435 1 Boundary Road, Newlands
City Postal code Country Position/Affiliation
Cape Town 7725 South Africa PhD Student
Role Name Email Phone Street address
Scientific Enquiries Robert Evans robertevanssa@gmail.com 0729852435 Sport Science Institute of South Africa, 1 Boundary Road, Newlands
City Postal code Country Position/Affiliation
Cape Town South Africa PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information