What Are the Effects of a Bilateral Hip Exoskeleton During Daily Use by 65+ Adults?
- Conditions
- Pre-frail Senior Adults
- Interventions
- Device: Exoskeleton
- Registration Number
- NCT06041100
- Lead Sponsor
- Aalborg University
- Brief Summary
Despite the huge popularity exoskeletons have gained in the past years and the benefits that they have shown to provide to users, there are still many aspects of wearing an exoskeleton that have yet to be determined. Therefore, the main objective of this study is to evaluate the feasibility using the acceptability of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks. The second aim of the study is to determine whether this effect can be sustained even after a period of 6-weeks following the cessation of usage.
- Detailed Description
Despite the high benefits of performing physical activity in terms of physical and cognitive function, between 27-38% of Danish older adults do not meet the required physical activity recommendations. Due to the longer life expectancy, the increasingly older population will face gait disorders. These gait disorders will affect their motor and cognitive functions, and impair the performance of daily physical activity and overall quality of life. Frailty is one of the most frequent aging-related deficits observed in older adults, often characterized by three of the following criteria: unintentional weight loss \>4.5 kg within the last year, exhaustion, loss or slower mobility, loss of grip strength, and low physical activity. However, pre-frail adults may present some of the aforementioned criteria and a score of ≤5 on the Tilburg Frailty Indicator. Therefore, there is an increasing need to provide the aging population with devices capable of promoting physical activity and independent living. Exoskeletons have been shown to facilitate physical activity in the older adult population by improving metabolic costs, increasing walking speed, and preventing falls. However, whether these benefits are only temporary, or can be maintained over a longer period, remains to be determined. Therefore, it is of pivotal importance to assess the long-term effects of exoskeletons, in terms of mobility, within the older adult population.
The use of external mechanical walking devices started in the late 1890s. However, only in the past two decades have gait-assisting exoskeletons, with increased human performance capability, gained popularity. Exoskeletons have been shown to reduce metabolic cost, and fatigue onset and increase walking velocity. Currently on the market, there are several lower-limb exoskeletons that target older populations and people with gait and neurological disabilities which are designed to enhance walking performance and reduce the muscle activation required during walking activities. Wearing gait-assisting exoskeletons can provide instant ease, delay fatigue onset, increase social engagement, and support rehabilitation to recover normal walking capabilities. The effects of hip exoskeletons have been previously investigated in terms of quality of life and improvement of gait performance. However, the effect of long-term use has yet to be assessed. Hence, this study aims to evaluate the impact of extended usage of a non-invasive passive hip exoskeleton on the quality of life of older adults. This will be achieved by analyzing the spatiotemporal gait characteristics in a feasibility study conducted over a 12-week period of consistent device usage. Additionally, the study aims to ascertain the persistence of these effects for a duration of 6 weeks post-usage.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- score of ≤ 5 on the Tilburg Frailty index
- able to walk independently without walking aids.
- score of >6 on the Tilburg Frailty index
- uncorrected visual or hearing impairments
- Vestibular dysfunctions
- current use of walking aids.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Exoskeleton 30 minutes of daily wearing an exoskeleton for 12-weeks
- Primary Outcome Measures
Name Time Method Step length Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial Changes in step length (cm) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
Walking speed Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial Changes in speed (m/s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
Double support time Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial Changes in double support time (s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
Cadence Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial Changes in cadence (steps/minute) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
- Secondary Outcome Measures
Name Time Method Heart rate Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial using a chest strap device which will be monitored during the gait measurement
Perceived effort Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using Borg Category-Ratio (CR) scale (0 = No effort, 10 = Maximal effort) to evaluate the work tasks conducted during the pre- and post-tests.
Physical activity levels Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using a questionnaire (The International Physical Activity Questionnaire) to determine the kind and level of the physical activity performed within the past 7 days. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Self-reporting of exoskeleton-use during the 12-weeks intervention Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using yes/ no, metric and open-ended questions on usage: Q1: "Did you wear the device this week?", Q2: "How much did you wear the device every day? " Q3: "What activities did you predominately performed with the device?". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Life quality Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using a questionnaire the EQ-5D-5L which evaluates five dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety, and discomfort) at five severity levels ranging from no effect/symptom to slightly, moderate, severe, and extreme.
Age Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial will be collected as descriptive statistics and for the inclusion criteria.
Acceptability Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks using the acceptability questionnaire that has a 7-point Liker scale ranging from "very unacceptable" to "very acceptable".
BMI Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial will be assessed by collecting weigth and height.
Wearability Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using yes/ no and open-ended questions on ease/discomfort of wearing the device: Q1: "Did you have any technical problems with the device broken/stuck?" Q2: "Did you have any physical problems with the device pain/discomfort?" Q3: "Did see or feel any improvements in your ability to walk?" 4. "How would you describe your experience so far in few words? ". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
Qualitative data Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.] Assessed using a semi-constructed interview with yes/ no and open-ended questions on the overall experience of using the device.
Frailty Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial assessed using a questionnaire the Tilburg Frailty Index which evaluates frailty levels for the inclusion criteria.
Trial Locations
- Locations (1)
Aalborg University
🇩🇰Gistrup, Nordjylland, Denmark