NCT03588663

Effect of Using a Bionic Leg on Physiological and Biomechanical Measures in Stroke Patients

The Acute Effect of Using a Bionic Leg on Physiological Cost Index and Biomechanical Measures in Chronic Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Winchester · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will assess the effect of wearing a wearable bionic leg, on the physiological cost index and biomechanical measures in patients with stroke. Patients will be tested during a range of activities (sit-to-stand, walking) with and without the Bionic Leg, and following a 30-min training program.

Detailed description

The aim of this study is to investigate the acute effect of wearing a Bionic Leg on: 1. The Physiological Cost Index (PCI) and Biomechanical measures (gait, postural sway) of stroke patients compared to when they do not wear a Bionic Leg. 2. Whether after wearing a Bionic Leg for 30-minutes during a training session influences the Physiological Cost Index (PCI) and any Biomechanical measures (gait, postural sway) of stroke patients Individuals who volunteer to participate in the present study will be asked to engage in 4 sessions in the laboratory. Firstly, participants will be asked to take part in two familiarisation sessions, which will be delivered on two separate occasions. These sessions will last one-hour each and will allow participants (stroke patients) to become accustomed to wearing and using the Bionic Leg. Sessions will consist of sit to stand, walking and stairs exercises, which will allow individuals to become familiarised with the Bionic Leg device. They will then be asked to complete 6x 10m walks to identify their self-selected walking pace. In session 3, individuals will be randomly assigned to either use the Bionic Leg, or not. Participants will initially be asked to stay seated and rested for 5 minutes so a resting heart rate can be taken. If participants are assigned to the Bionic Leg condition first, they will conduct all the following tests with the Bionic leg on, however, if not, they will perform all the tests without wearing the Bionic Leg. They will then partake in a 3-minute walk test, which will include walking at their self-selected pace (found in session 1) for 3 minutes. Following this a 15-minute rest period will be taken, and 3 x timed-up and go tests will be conducted (see outcome measures). Next, participants will be asked to take part in a balance test, and then a 6-minute walk test (see outcome measures). Following a 15-minute rest, participants will complete 10 x sit-to-stands. During the testing session where participants are not wearing the Bionic Leg, once they have finished all of the above testing, participants will engage in further testing during this session. Following a 15-minute recovery period participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. Following this, individuals will be given a further 15-min rest period, and the original tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) which were detailed above, would be re-assessed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.

Conditions

• Stroke
• Physical Activity
• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	Baseline Bionic Leg Assessment	The 'Bionic Leg' (BL) \[Alter G, Fremont, CA, USA; approved by the Food and Drug Administration (FDA) in 2014\], is an externally-wearable, battery-operated robotic device that assists patients and therapists during rehabilitation by providing adjustable and progressive functional mobility training. A patient or therapist can programme the BL to provide motor assistance during sit-to-stand exercises, over-ground walking, and stair climbing, with either more or less robotic-assistance, as desired by the therapist. As the BL increases stability and actively engages the affected leg during functional tasks, it enables patients to undertake more repetitions of specific tasks than when not wearing a BL.
OTHER	Baseline Control Condition Assessment	Participants will complete identical tasks as that undertaken with the Bionic Leg, but will complete the tasks without wearing the Bionic Leg.
OTHER	Training	Participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. The training programme will include a 15-minute rest period after completion of the 30 minutes of exercises. This will take 45 minutes in total.
OTHER	Follow-up Assessment	45 minutes after the baseline assessment, immediately following the Training programme, the following tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) will be completed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.

Timeline

• Start date: 2018-08-10
• Primary completion: 2018-10-08
• Completion: 2018-10-08
• First posted: 2018-07-17
• Last updated: 2018-10-11

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study