Cognitive Decline, Gait Disorders in Old Age, Mild Cognitive Impairment
Conditions
Brief summary
The primary aim of this pilot study is to investigate the effect of Walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the Saint Louis University Mental Status (SLUMS) Examination.
Detailed description
The Walkasins system is one of a growing number of wearable devices that use various modalities of neuromodulation, defined as the alteration of nerve activity through targeted delivery of a stimulus . . . to specific neurological sites in the body (https://www.neuromodulation.com/). Because these technologies are relatively new, innovative applications of their use in various patient populations may lead to improvements in the care and quality of life of individuals who suffer from these life-altering diagnoses. Previous studies of Walkasins have shown that individuals with peripheral neuropathy who have gait and balance problems walk faster with the Walkasins device. This increase may be related to an improved automaticity of gait function, which decreases the need for cognitive attention to the walking task, which is known to slow down gait. Individuals with mild cognitive impairment commonly show slow gait speeds, likely due to a decline in executive function. There is a reason to think that sensory stimuli from the Walkasins device can improve the automaticity of gait in these individuals and thereby enhance gait speed.
Interventions
DEVICEWalkasins
Walkasins is a non-invasive, wearable, lower limb sensory prosthesis, prescribed by a healthcare professional for long-term daily use as a prosthesis. It directly replaces the part of the function of the sensory end organs that persons with peripheral neuropathy have lost, the sensation in the soles of their feet. The system is comprised of two primary operating components: * A Receptor Sole, properly placed in the shoe, detects and transmits plantar pressure information normally performed by the mechanoreceptors and distal axons in the soles of the feet. * A Haptic Module, worn around the lower leg, generates directional specific mechanical tactile stimuli that produce action potentials that signal relevant balance information to the nervous system.
Sponsors
Innovative Design Labs
RxFunction Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory person who is at least 65 years of age * Ability to understand and provide informed consent * Ability to perceive vibrations from the Walkasins Haptic Module * Ability to complete the functional outcome measures without the use of an assistive device * Foot size that allows the Walkasins to function appropriately * Mild Cognitive Impairment (MCI) as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 + or -2 for those with less than a high school education and scores between 21-26 + or -2 for those who graduated from high school, which indicate mild cognitive impairment) and/or a diagnosis of MCI (or related term) in the person's medical record * Slow gait speed (\<1m/second or slightly faster, provided all other criteria are met)
Exclusion criteria
* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins * Self-reported acute thrombophlebitis including deep vein thrombosis * Untreated lymphedema * Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use * Untreated fractures in the foot and ankle * Self-reported severe peripheral vascular disease * Other neurological conditions that impact walking (e.g., peripheral neuropathy) * Weighs more than 300 pounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) | 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition) | The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB) | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) | The Short Physical Performance Battery measures walking speed, standing balance, and sit-to-stand performance. Scores on balance, gait speed, and chair-stand tests are added (summed) for a total score. (Scores on balance, gait speed, and chair-stand tests are not reported separately since they are not subscales per se.) SPPB scores may range from 0 to 12. Higher total scores indicate better balance and gait. |
| Timed Up and Go (TUG) | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) | The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command Go until the subject sits down again. Lower times indicate better/faster performance. |
| Timed Up and Go Cognitive (TUG-COG) | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) | The TUG-COG is performed similarly to the TUG; however, the participant is also asked to count backwards by 3 from a randomly selected number between 20 and 100 while performing the TUG (standing up from the chair, walking to a line on the floor 10 feet away, turning, walking back to the chair at a normal pace, and sitting down again). Lower times indicate better/faster performance. |
| Falls Efficacy Scale | Once During 1 Session <1.5 Hours | The Falls Efficacy Scale is a 16-item questionnaire that measures an individual's fear of falling or concerns about falling during activities of daily living. Scores may range from 16 (not at all concerned) to 64 (very concerned). Lower scores are better than higher scores because they indicate less concern about falling. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Walkasins and PhySens-IMM System--Single Arm Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments first with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Walkasins and PhySens-IMM System--Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 84.8 Years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 12 participants |
| Saint Louis University Mental Status (SLUMS) Test | 23.5 Score on a Scale STANDARD_DEVIATION 2.6 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.)
Time frame: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) | Baseline Assessment for Eligibility | 0.79 Meters/Second | Standard Deviation 0.16 |
| Walkasins and PhySens-IMM System--Single Arm | Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) | Walkasins OFF | 0.82 Meters/Second | Standard Deviation 0.18 |
| Walkasins and PhySens-IMM System--Single Arm | Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) | Walkasins ON | 0.79 Meters/Second | Standard Deviation 0.2 |
Secondary
Falls Efficacy Scale
The Falls Efficacy Scale is a 16-item questionnaire that measures an individual's fear of falling or concerns about falling during activities of daily living. Scores may range from 16 (not at all concerned) to 64 (very concerned). Lower scores are better than higher scores because they indicate less concern about falling.
Time frame: Once During 1 Session <1.5 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Falls Efficacy Scale | 32.2 Score on a Scale | Standard Deviation 7.6 |
Secondary
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery measures walking speed, standing balance, and sit-to-stand performance. Scores on balance, gait speed, and chair-stand tests are added (summed) for a total score. (Scores on balance, gait speed, and chair-stand tests are not reported separately since they are not subscales per se.) SPPB scores may range from 0 to 12. Higher total scores indicate better balance and gait.
Time frame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Short Physical Performance Battery (SPPB) | Walkasins OFF | 8.2 Score on a Scale | Standard Deviation 1.9 |
| Walkasins and PhySens-IMM System--Single Arm | Short Physical Performance Battery (SPPB) | .Walkasins ON | 7.5 Score on a Scale | Standard Deviation 2.1 |
Secondary
Timed Up and Go Cognitive (TUG-COG)
The TUG-COG is performed similarly to the TUG; however, the participant is also asked to count backwards by 3 from a randomly selected number between 20 and 100 while performing the TUG (standing up from the chair, walking to a line on the floor 10 feet away, turning, walking back to the chair at a normal pace, and sitting down again). Lower times indicate better/faster performance.
Time frame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Timed Up and Go Cognitive (TUG-COG) | Walkasins OFF | 21.64 Seconds | Standard Deviation 7.1 |
| Walkasins and PhySens-IMM System--Single Arm | Timed Up and Go Cognitive (TUG-COG) | Walkasins ON | 18.85 Seconds | Standard Deviation 6.96 |
Secondary
Timed Up and Go (TUG)
The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command Go until the subject sits down again. Lower times indicate better/faster performance.
Time frame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Timed Up and Go (TUG) | Walkasins OFF | 15.46 Seconds | Standard Deviation 5.4 |
| Walkasins and PhySens-IMM System--Single Arm | Timed Up and Go (TUG) | Walkasins ON | 15.83 Seconds | Standard Deviation 5.66 |