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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
Evans RW, Shackleton CL, West S, Derman W, Laurie Rauch HG, Baalbergen E, Albertus Y
Archives of Physical Medicine and Rehabilitation 2021 Aug;102(8):1447-1456
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 and 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 = 0.05). 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.

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