N/A
N=16
Powered Orthotic Exoskeleton Training in Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04241848 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Five Times Sit to Stand Test (5xSTS) — -20.3; -10.9; -9.3 seconds — p==0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Keeogo (Device); Ambulation training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five Times Sit to Stand Test (5xSTS) |
-20.3; -10.9; -9.3 | =0.007 sig |
| SECONDARY Energy Expenditure |
— | — |
| SECONDARY The Ratio of Stance Time of Each Limb During Ambulation |
— | — |
| SECONDARY Six Minute Walk Test (6MWT) |
59.8; 67; 57.8 | 0.129 |
| SECONDARY Ten Meter Walk Test (10MWT) |
0.24; 0.19; 0.17 | =0.091 |
| SECONDARY Timed Up and Go (TUG) Test |
-5.9; -3.3; -6.7 | 0.063 |
| SECONDARY Step Length of Paretic (Pa) Lower Extremities (LE) |
8.4; 2.2; 9.3 | 0.035 sig |
| SECONDARY Step Length of Non-paretic (NP) Lower Extremities (LE) |
6.4; 2.3; 8.7 | =0.098 |
| SECONDARY Stair Climb Power Test (SCPT) |
-7.3; -8.1; -9.3 | =0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (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;
- 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).
Data sourced from ClinicalTrials.gov (NCT04241848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.