Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait training with exoskeleton resistance | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle resistance and biofeedback | Device | An ankle exoskeleton will provide stance phase resistance and a plantar pressure biofeedback system will encourage late stance push-off. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6MWT | Change (post - baseline) in six minute walk test distance (distance in meters) | Baseline assessment and 1-week post training assessment (at 5 weeks) |
| Change in Metabolic Power | Change (post - baseline) in metabolic power measured in J/(kgm) | Baseline assessment and 1-week post training assessment (at 5 weeks) |
| Change in Plantar Flexor Force Production | Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg | Baseline assessment and 1-week post training assessment (at 5 weeks) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona University | Flagstaff | Arizona | 86011 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
>65 years old
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 6MWT | Change (post - baseline) in six minute walk test distance (distance in meters) | Posted | Mean | Standard Deviation | m | Baseline assessment and 1-week post training assessment (at 5 weeks) |
|
|
Approximately 4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | Northern Arizona University | 928-523-1787 | Zachary.Lerner@nau.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2024 | Feb 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2025 | Jun 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2024 | Feb 6, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Change in Metabolic Power | Change (post - baseline) in metabolic power measured in J/(kgm) | Posted | Mean | Standard Deviation | J/(kgm) | Baseline assessment and 1-week post training assessment (at 5 weeks) |
|
|
|
| Primary | Change in Plantar Flexor Force Production | Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg | Posted | Mean | Standard Deviation | N/kg | Baseline assessment and 1-week post training assessment (at 5 weeks) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |