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Robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. These devices can assist in overcoming gravitational forces and reduce energy consumption. Agilik is one such device intended for individuals with neurological disorders. However, Agilik is relatively new, and its efficacy in individuals with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for individuals with CP and crouch gait. In this pilot study, ten individuals with CP, GMFCS levels I and II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with shoes or AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in individuals with CP.
Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the effectiveness of this technology in individuals with CP is unknown. This study aims to assess the efficacy of Agilik as an assistive device for individuals with CP. Ten individuals with CP, ages 8 to 65 years, and at GMFCS levels I and II, will be recruited for this pilot study. Each individual will participate in a maximum of four sessions/ visits. The first three sessions will include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclimation. These sessions will last up to 60 minutes. A two-minute walk test (2MWT) will also be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/ practice. The final visit will include 2MWT and 3D motion capture in shod (shoes or shoes+AFO) and RKO-assisted (shoes+RKO or shoes+AFO+RKO) conditions, and may take up to 3 to 4 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RKO-assisted walking in individuals with CP | Device | The investigators will assess walking in each of the following conditions: shod (shoes or shoes+AFO) and RKO-assisted (shoes+RKO or shoes+AFO+RKO), to achieve the following: (1) Evaluate the effect of RKO, compared to shod upon endurance in individuals with CP at GMFCS levels I and II, and (2) Evaluate the effect of RKO, compared to shod, upon temporal-spatial parameters, lower limb sagittal joint kinematics, and muscle EMG in individuals with CP at GMFCS levels I and II. |
| Measure | Description | Time Frame |
|---|---|---|
| Distance from 2MWT | The distance covered by participants during a two-minute walking test (2MWT) will be compared between RKO-assisted and shod conditions. | From enrollment until data collection is performed on the fourth study session. |
| Step length | Mean step length (distance between the two feet measured from the heel of one foot to the heel of the contralateral foot while both feet are on the ground) during walking will be compared between RKO-assisted and shod conditions. | At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |
| Single limb support time | Mean single limb support time (duration just one foot by itself is on the ground) during walking will be compared between RKO-assisted and shod conditions. | At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |
| Walking speed | Mean walking speed during walking will be compared between RKO-assisted and shod conditions. | At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |
| Lower limb joint kinematics | The sagittal plane lower limb joint angles (degrees) during walking will be compared to evaluate the difference between RKO-assisted and shod conditions. | At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |
| Binary indicator of improvement in walking distance with RKO use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
The study results (de-identified) will be disseminated in conference abstracts and peer-reviewed journal articles.
Within 12 months of the trial completion.
Data and supporting information will be shared upon reasonable request to the PI. After the PI reviews and approves the applicant's request, de-identified information will be provided.
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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"Yes" if the walking distance in the RKO-assisted condition was greater than shod, and "No" if there was no improvement. |
| At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |
| Lower limb electromyography data | Electromyography (EMG) amplitude and duration of lower limb anti-gravity muscles (rectus femoris, vastus lateralis, vastus medialis, medial gastrocnemius, soleus, and gluteus maximus) will be compared between RKO-assisted and shod conditions. The EMG data will be filtered and rectified to compute linear envelopes. From these envelopes, the average value of EMG amplitude and duration will be compared between RKO-assisted and shod conditions. | At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment. |