Sarcopenia
Conditions
Brief summary
The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.
Detailed description
The overarching goal of this study is to improve mobility in older adults through advances in wearable assistance (i.e. powered orthoses). This goal will be accomplished by focusing on two specific research aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals. Several powered orthosis conditions will be tested during several modes of walking or running and balance throughout the course of the study. Trials will take place over-ground and/or on a treadmill. Balance trials will take place on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue; a maximum of 15 minutes of continuous walking will take place between breaks.
Interventions
DEVICEAnkle resistance and biofeedback
An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off.
Sponsors
Northern Arizona University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 65 and 85 years old, inclusive. * Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination. * Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used. * The ability to read and understand English. * Able to walk at least 30 feet with or without a walking aid * Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
Exclusion criteria
* Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time. Note: For elderly participants, a history of joint replacement or joint degeneration that does not impair their ability to walk safely is allowable. * Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6MWT | Baseline assessment and 1-week post training assessment (at 5 weeks) | Change (post - baseline) in six minute walk test distance (distance in meters) |
| Change in Metabolic Power | Baseline assessment and 1-week post training assessment (at 5 weeks) | Change (post - baseline) in metabolic power measured in J/(kgm) |
| Change in Plantar Flexor Force Production | Baseline assessment and 1-week post training assessment (at 5 weeks) | Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gait Training With Exoskeleton Resistance Participants will complete 20-30 minutes of ankle resistance training on each visit. This will involve walking on a treadmill with stance phase ankle resistance and biofeedback.
Ankle resistance and biofeedback: An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gait Training With Exoskeleton Resistance | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in 6MWT
Change (post - baseline) in six minute walk test distance (distance in meters)
Time frame: Baseline assessment and 1-week post training assessment (at 5 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gait Training With Exoskeleton Resistance | Change in 6MWT | 48.3 m | Standard Deviation 50.5 |
Primary
Change in Metabolic Power
Change (post - baseline) in metabolic power measured in J/(kgm)
Time frame: Baseline assessment and 1-week post training assessment (at 5 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gait Training With Exoskeleton Resistance | Change in Metabolic Power | -0.09 J/(kgm) | Standard Deviation 0.58 |
Primary
Change in Plantar Flexor Force Production
Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg
Time frame: Baseline assessment and 1-week post training assessment (at 5 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gait Training With Exoskeleton Resistance | Change in Plantar Flexor Force Production | 0.6 N/kg | Standard Deviation 0.2 |