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Iida S1,2, Kawakita D2, Hujita T2, Kotaki T2, Ikeda K2, Aoki C1
1Teikyo Heisei University, Physical Therapy, Tokyo, Japan, 2Chiba Tokusyukai Hospital, Rehabilitation, Chiba, Japan
Background: Recent advances in robotic technology have made inroads into rehabilitation.
The Bionic-Leg (Alter-G, Sunnyvale, CA, USA) is a portable, wearable, battery-powered knee-ankle-foot orthosis with active robot assisting technology (also referred to as the robotic knee orthosis [RKO]). This training orthosis supports knee mobility when standing or walking. Our pilot study examined the effects of RKO-assisted exercise for five patients with chronic symptoms after stroke, using a baseline-treatment-return to Baseline (ABA)-type single-case study design. The stride length, the step length, the duration of one-leg support time, and the 10-meter (m) gait time improved after the RKO exercises. However, this investigation had major limitations in that it was a single-case study design with no statistical analyses.
Purpose: The purpose of this study is to examine the effects of walking ability and balancing ability of exercise using the RKO for patients in the recovery phase of stroke in a randomized controlled trial (RCT).
Methods: The participants comprised 28 patients who were in a recovery phase rehabilitation ward following a stroke. Inclusion criteria were first stroke with hemiplegia, Brunnstrom Recovery Stage of III or IV for the leg and independent or supervision-only static sitting and standing ability. The participants were divided randomly into two groups: the RKO group (exercise group using the RKO) and the conventional group (exercise group without the RKO). The intervention term was 10 days. The intervention consisted of 60 minutes of standard-of-care physical therapy, followed by 20 minutes of exercise by each of the two groups. Participants were evaluated three times pre-intervention, post-intervention and one month post intervention. The clinical data measured were gait speed, cadence, stride length, the left-right symmetry of the step length , the percentage of one-leg support period of the paresis and non-paresis side during the walking cycle, the left-right symmetry of the one-leg support period during the walking cycle, the BBS and the FIM . The types of exercise in the additional 20 minutes consisted of a squatting exercise (5 minutes), a step exercise (5 minutes), and a walking exercise (10 minutes). The number of times the squatting and step exercises were performed was recorded; the walking distance was also recorded. Clinical datas were analyzed using a two-way repeated measures ANOVA. The amount of exercises were analyzed using non-paired t test.
Results: The percentage of one-leg support period of paresis side during the walking cycle and the left-right symmetry of the one-leg support period during the walking cycle were significantly increased in the RKO group at evaluation of post-intervention. The percentage of one-leg support period of paresis side during the walking cycle was also increased at evaluation of one month post intervention. The amount of squatting and step exercises was also significantly increased in the RKO group.
Conclusion(s): The present study is the first RCT to show the effect of the RKO. It was suggested that exercise using the RKO could increase the amount of exercise and improve the ability of weight-shift to the paralytic lower extremity.
Implications: RKO is expected to be one of the tools for rehabilitation treatment.
Keywords: Robotics Knee Orthosis, RCT, Stroke
Funding acknowledgements: This work was supported by JSPS KAKENHI [Grant-in Aid for Young Scientists (B): [16K16441].
The Bionic-Leg (Alter-G, Sunnyvale, CA, USA) is a portable, wearable, battery-powered knee-ankle-foot orthosis with active robot assisting technology (also referred to as the robotic knee orthosis [RKO]). This training orthosis supports knee mobility when standing or walking. Our pilot study examined the effects of RKO-assisted exercise for five patients with chronic symptoms after stroke, using a baseline-treatment-return to Baseline (ABA)-type single-case study design. The stride length, the step length, the duration of one-leg support time, and the 10-meter (m) gait time improved after the RKO exercises. However, this investigation had major limitations in that it was a single-case study design with no statistical analyses.
Purpose: The purpose of this study is to examine the effects of walking ability and balancing ability of exercise using the RKO for patients in the recovery phase of stroke in a randomized controlled trial (RCT).
Methods: The participants comprised 28 patients who were in a recovery phase rehabilitation ward following a stroke. Inclusion criteria were first stroke with hemiplegia, Brunnstrom Recovery Stage of III or IV for the leg and independent or supervision-only static sitting and standing ability. The participants were divided randomly into two groups: the RKO group (exercise group using the RKO) and the conventional group (exercise group without the RKO). The intervention term was 10 days. The intervention consisted of 60 minutes of standard-of-care physical therapy, followed by 20 minutes of exercise by each of the two groups. Participants were evaluated three times pre-intervention, post-intervention and one month post intervention. The clinical data measured were gait speed, cadence, stride length, the left-right symmetry of the step length , the percentage of one-leg support period of the paresis and non-paresis side during the walking cycle, the left-right symmetry of the one-leg support period during the walking cycle, the BBS and the FIM . The types of exercise in the additional 20 minutes consisted of a squatting exercise (5 minutes), a step exercise (5 minutes), and a walking exercise (10 minutes). The number of times the squatting and step exercises were performed was recorded; the walking distance was also recorded. Clinical datas were analyzed using a two-way repeated measures ANOVA. The amount of exercises were analyzed using non-paired t test.
Results: The percentage of one-leg support period of paresis side during the walking cycle and the left-right symmetry of the one-leg support period during the walking cycle were significantly increased in the RKO group at evaluation of post-intervention. The percentage of one-leg support period of paresis side during the walking cycle was also increased at evaluation of one month post intervention. The amount of squatting and step exercises was also significantly increased in the RKO group.
Conclusion(s): The present study is the first RCT to show the effect of the RKO. It was suggested that exercise using the RKO could increase the amount of exercise and improve the ability of weight-shift to the paralytic lower extremity.
Implications: RKO is expected to be one of the tools for rehabilitation treatment.
Keywords: Robotics Knee Orthosis, RCT, Stroke
Funding acknowledgements: This work was supported by JSPS KAKENHI [Grant-in Aid for Young Scientists (B): [16K16441].
Topic: Robotics & technology; Neurology: stroke
Ethics approval required: Yes
Institution: Teikyo Heisei University
Ethics committee: the Ethics Committee of Teikyo Heisei University
Ethics number: No 27-083
All authors, affiliations and abstracts have been published as submitted.
