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

NCT03588663 | Completed DMC FDA Device

• 1 other identifier: Wright_BL_Acute_2018
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Physical Activity; Gait, Hemiplegic

Keywords

Robotics; Walking; Balance

Outcome Measures

Primary Outcomes (1)

• Change in Physiological Cost Index between baseline and follow-up

  Physiological Cost Index is a measure of energy expenditure. The Physiological Cost Index is collected from a 3-min walking test. Prior to the test, participants remain seated for 5-mins so a resting heart rate can be recorded. It is anticipated the resting heart rate will be between 40 and 80 beats per minute. Lower heart rates are considered better than higher heart rates at rest. Thereafter, participants will walk for 3 minutes at a self-selected walking pace. Heart rate will be recorded throughout. It is anticipated that the heart rate at the end of 3 minutes will be between 80 and 120 beats per minute. Lower heart rates will be seen to be better than higher heart rates. Physiological Cost Index is calculated by (Heart rate during steady state exercise - heart rate at rest)/walking speed. The smaller change in heart rate between rest and the end of the 3 minute test, the better the Physiological Cost Index.

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)

Secondary Outcomes (5)

• Change in Timed-Up-and-Go between baseline and follow-up

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)

• Change in Postural Sway between baseline and follow-up

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)

• Change in Gait analysis between baseline and follow-up

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Post-Training Program Assessment

• Change in 6-min walk test between baseline and follow-up

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)

• Change in Sit-to-Stand between baseline and follow-up

  Baseline Bionic Leg Assessment; Baseline Control Condition Assessment; Follow-up Assessment (2 hours post-baseline)

Study Arms (2)

Bionic Leg

EXPERIMENTAL

Participants will wear the Bionic Leg during a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises.

Device: Baseline Bionic Leg Assessment

Control

ACTIVE COMPARATOR

Participants will complete a series of different activities including a timed-up-and-go, balance tests, 6-min walk test and sit-to-stand exercises without wearing the bionic leg (control condition).

Other: Baseline Control Condition Assessment; Other: Training; Other: Follow-up Assessment

Interventions

Baseline Bionic Leg Assessment DEVICE

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.

Bionic Leg

Baseline Control Condition Assessment OTHER

Participants will complete identical tasks as that undertaken with the Bionic Leg, but will complete the tasks without wearing the Bionic Leg.

Control

Training OTHER

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.

Control

Follow-up Assessment OTHER

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of stroke within 3 months to 5 years of study start date.
• Community patients who are medically stable and are either (1) currently receiving physical therapy from a neurophysiotherapy practice or (2) attending a community-based stroke support group and do not actively receive physical therapy.
• Individuals who are able to stand and step with an aid or assistance
• Patients who are cognitively aware to undertake rehabilitation exercises, physical therapy and activity.
• Patients whose height is 1.58-1.92m
• Patients whose weight is less than 159kg.

You may not qualify if:

• Unresolved deep-vein thrombosis
• Unstable cardiovascular conditions
• Open wounds
• Active drug resistant infections
• Recent fractures of involved limb
• Peripheral arterial disease
• Incontinence
• Severe osteoporosis
• Non-weight bearing

Sponsors & Collaborators

• University of Winchester: lead
• University College Dublin: collaborator

Study Sites (1)

Centre for Sport

Winchester, Hampshire, SO22 4NR, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Motor Activity; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded outcomes assessor will analyse all data. Participants will not be blinded from the study as they will know whether they are using the Bionic Leg in a given testing session or not.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 17, 2018
• Study Start: August 10, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)