Powered Orthotic Exoskeleton Training in Stroke
- Conditions
- Stroke
- Interventions
- Other: Ambulation trainingDevice: Keeogo
- Registration Number
- NCT04241848
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.
- Detailed Description
Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement.
This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (\>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide.
The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Males and female between 18 and 89 years old;
- Hemiplegia or hemiparesis due to stroke (>6 months);
- [Able to walk between 0.15-0.75m/s]
- Self-reported limitations to mobility and walking activities due to paretic side knee stiffness and loss of range of motion;
- Weight under 250lbs
- Desire to increase daily activity levels; and
- Able and willing to commit to participation and follow directions and communicate basic needs.
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Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
-
Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
-
Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
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Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the 6MWT
-
Anthropometric incompatibility with the device
- Femur length less than 36 cm or greater than 45 cm;
- Upper thigh circumference less than 55 cm or greater than 75 cm;
- Lower thigh circumference less than 27 cm or greater than 40 cm;
- Calf circumference less than 33 cm or greater than 49 cm;
- Ankle circumference less than 27 cm or greater than 40 cm;
- Shin length less than 26 cm;
- Waist circumference less than 71 cm or greater than 107 cm;
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Any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions); and
-
Pregnant or planning to become pregnant (Females only).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Ambulation training Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Powered Orthotic Exoskeleton Training Group Keeogo Participant in 36 session ambulation training using a powered orthotic exoskeleton. Powered Orthotic Exoskeleton Training Group Ambulation training Participant in 36 session ambulation training using a powered orthotic exoskeleton.
- Primary Outcome Measures
Name Time Method Five Times Sit to Stand Test (5xSTS) Change from Baseline after completing 36 training sessions (approximately three months time) The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device.
- Secondary Outcome Measures
Name Time Method energy expenditure Change from Baseline after completing 36 training sessions (approximately 3 months time) Energy expenditure was completed due to equipment malfunction of the portable metabolic cart and the inability to have it fixed during the COVID-19 pandemic.
The ratio of stance time of each limb during ambulation Change from Baseline after completing 36 training sessions (approximately three months time) Stepping parameters were initially planned to be assessed using an instrumented carpet to determine if the paretic limb has a more equitable and symmetrical load. While data was initially collected, this outcome measure was not analyzed in favor of step length.
Six Minute Walk Test (6MWT) Change from Baseline after completing 36 training sessions (approximately three months time) The 6MWT was used to assess walking endurance and was conducted on a straight 12-meter length in the hospital hallway, with a small cone marking each end of the length. Participants were instructed to walk as far as possible, at a self-selected comfortable pace, for 6 minutes while a trainer followed behind them. Participants were allowed to slow down, stop, and rest if necessary if they felt fatigued during the test. The number of completed lengths (of the 12-meter stretch of the hospital hallway) was recorded and the distance in meters was calculated.
Ten Meter Walk Test (10MWT) Change from Baseline after completing 36 training sessions (approximately three months time) The 10MWT was used to assess gait speed. Participants were instructed to walk at their own comfortable pace along a 14-meter flat course in the hospital hallway while a trainer followed behind them. The initial and final two meters were used for acceleration and deceleration, respectively, while the middle ten meters of the course were times in seconds. Participants were allowed two trails, and the fastest elapsed time was used to calculate gait speed in meters/seconds.
Timed Up and Go (TUG) Test Change from Baseline after completing 36 training sessions (approximately three months time) The Timed Up and Go (TUG) Test was used as a reliable, objective measure of functional mobility. The participant was seated, with their back against the seatback, in a free-standing straight-backed chair with arms and a seat height of 17 inches. Participants were instructed to stand, walk three meters at a comfortable pace to a marked line, turn, walk back to the chair, and sit down. Timing started at the "start" command and stopped when the participant's buttocks touched the chair. Participants were allowed one practice trial prior to the timed trial.
Step Length of Paretic (Pa) and non-paretic (NP) Lower Extremities (LE) Change from Baseline after completing 36 training sessions (approximately three months time) Step lengths of the paretic (Pa) and non-paretic (NP) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait.
Stair Climb Power Test (SCPT) Change from Baseline after completing 36 training sessions (approximately three months time) The Stair Climb Power Test was used as a measure of lower extremity (LE) power and functional mobility. Participants were instructed to ascend a flight of 10 stairs as fast as possible, using the handrail as needed for safety. Participants stood at the base of the first step. Timing started on the assessor's "go" command and stopped when both feet of the participant reached the top of the tenth step.
Trial Locations
- Locations (1)
James J. Peters VA Medical Center, Bronx, NY
🇺🇸Bronx, New York, United States