Robotic Locomotor Training Leads to Cardiovascular Changes in Individuals With Incomplete Spinal Cord Injury Over a 24-Week Rehabilitation Period: A Randomized Controlled Pilot Study.

OBJECTIVE: To describe the effect of robotic locomotor training (RLT) and activity-based training (ABT) on cardiovascular indices during various physiological positions in individuals with spinal cord injury. DESIGN: Randomized controlled pilot study. SETTING: Private practice: Therapy & Beyond Centre - Walking with Brandon Foundation, Sports Science Institute of South Africa, Cape Town, South Africa. PARTICIPANTS: Participants with chronic traumatic motor incomplete tetraplegia (N=16) who resided in the Western Cape, South Africa. INTERVENTION: Robotic locomotor training (Ekso GT) and activity-based training over a 24-week intervention. MAIN OUTCOME MEASURES: Brachial and ankle blood pressure, heart rate, heart rate variability, and cardiovascular efficiency during 4 physiological positions. RESULTS: No differences between groups or over time were evident in resting systolic and diastolic blood pressure, ankle systolic pressure, ankle brachial pressure index, and heart rate variability. Standing heart rate at 24 weeks was significantly higher in the ABT group (95.58±12.61 beats/min) compared with the RLT group (75.14±14.96 beats/min) (P=.05). In the RLT group, no significant changes in heart rate variability (standard deviation R-R interval and root mean square of successive differences) was found between the standing and 6-minute walk test physiological positions throughout the intervention. Cardiovascular efficiency in the RLT group during the 6-minute walk test improved from 11.1±2.6 at baseline to 7.5±2.8 beats per meter walked at 6 weeks and was maintained from 6 to 24 weeks. CONCLUSIONS: Large effect sizes and significant differences between groups found in this pilot study support the clinical effectiveness of RLT and ABT for changing cardiovascular indices as early as 6 weeks and up to 24 weeks of rehabilitation. RLT may be more effective than ABT in improving cardiac responses to orthostatic stress. Based on heart rate variability metrics, the stimulus of standing has comparable effects to RLT on the parasympathetic nervous system. Cardiovascular efficiency of exoskeleton walking improved, particularly over the first 6 weeks. Both the RLT and ABT interventions were limited in their effect on brachial and ankle blood pressure. A randomized controlled trial with a larger sample size is warranted to further examine these findings.

"I was like intoxicated with this positivity": the politics of hope amongst participants in a trial of a novel spinal cord injury rehabilitation technology in South Africa.

PURPOSE: This study discussed the reports by participants in a randomised controlled trial of a novel intervention for spinal cord injury (SCI) rehabilitation in Cape Town, South Africa. MATERIALS AND METHODS: Sixteen participants were randomised to rehabilitation involving the use of robotic locomotor training, a novel technology, or to a group receiving an activity-based intervention. All participants were interviewed before the intervention and at six months follow-up. RESULTS: In a context in which rehabilitation services for SCI are virtually non-existent, all participants approached the study with enthusiasm and expressed gratitude for participation. They had high hopes for what the programme could achieve, with many believing, perhaps incorrectly, that the programme would help them walk independently again. While hope and enthusiasm are useful for adherence to experimental intervention studies, there is a danger, especially in poorly resourced contexts, for participants to experience considerable disappointment following false hope not being realised. This raises important ethical issues for researchers interested in the potential of new technologies to promote health in poorly resourced contexts. CONCLUSIONS: For clinicians, the path between supporting positive emotions (which may lead to positive outcomes), and confronting unrealistic hope (which may lead to negative outcomes) may be difficult. Follow-up with participants after re-integration into their communities is important to determine long-term psychological impact.Pan African Clinical Trial Number: PACTR201608001647143IMPLICATIONS FOR REHABILITATIONIn low-resource contexts where there is a low level of access to rehabilitation services, such access in the context of a trial of a new intervention may engender hope in a group of people with spinal cord injury. This hope may increase when a new technology is used, as was the case in this study.Hope can be very helpful to people entering rehabilitation, but unrealistic hope and expectations may have negative implications in the longer term.In this study, expectations of participants centred, unrealistically, around regaining the ability to walk again, despite past experiences and medical advice suggesting otherwise.A thin line exists between supporting high expectations and confronting unrealistic hope. This conundrum is difficult for the clinician, as both inappropriate hope and undue pessimism about an intervention have the potential to cause harm.Participant follow-up after the end of any innovative trial is important, not just to monitor physical progress, but also, where necessary, to support participants through a potential period of disillusionment when they find their expectations have not been fully met.