Crouch GaitNCT06887764
Robotic Knee Orthosis-assisted Walking in CP
A study testing RKO-assisted walking in individuals with CP in people with Crouch Gait and Cerebral Palsy (CP), run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Crouch Gait, Cerebral Palsy (CP)
- What is being tested?
- RKO-assisted walking in individuals with CP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 25 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with cerebral palsy at GMFCS levels I and II
- Exhibits crouch gait
- Between 8 to 65 years of age
- Hip flexion contracture less than 10 degrees
- Knee flexion contracture less than 20 degrees when measured in prone with hips extended
- Thigh-foot angle is between 15 degrees (internal) to 30 degrees (external) in prone
- Can walk a minimum distance of 10 meters without stopping
Who cannot join
- No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries
- The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain
- Inability to participate in the study because of recent orthopedic surgery (within twelve months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy
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.
Read the detailed description
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.
- Conditions
- Crouch Gait, Cerebral Palsy (CP)
- Being tested
- RKO-assisted walking in individuals with CP
- Keywords
- Robotic Knee Orthosis, Crouch Gait, Flexed-knee Gait, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RKO-assisted walking in individuals with CPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait | Experimental | Not described Receives: Device: RKO-assisted walking in individuals with CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance from 2MWT
The distance covered by participants during a two-minute walking test (2MWT) will be compared between RKO-assisted and shod conditions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
"Yes" if the walking distance in the RKO-assisted condition was greater than shod, and "No" if there was no improvement.
Measured: 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.
Measured: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Feb 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crouch GaitStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Scher, MD, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887764
- Sponsor's protocol ID
- 2023-2299
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study results (de-identified) will be disseminated in conference abstracts and peer-reviewed journal articles.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06887764
- Acronym / sponsor ID
- 2023-2299
- Conditions
- Crouch Gait, Cerebral Palsy (CP)
- Keywords
- Robotic Knee Orthosis, Crouch Gait, Flexed-knee Gait, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait | Experimental | Device: RKO-assisted walking in individuals with CP |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with cerebral palsy at GMFCS levels I and II
- Exhibits crouch gait
- Between 8 to 65 years of age
- Hip flexion contracture less than 10 degrees
- Knee flexion contracture less than 20 degrees when measured in prone with hips extended
Key exclusion criteria (3 listed)
- No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries
- The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain
- Inability to participate in the study because of recent orthopedic surgery (within twelve months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RKO-assisted walking in individuals with CPThe 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. | Device | Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait |
Primary outcome
Distance from 2MWT
Time frame: From enrollment until data collection is performed on the fourth study session.
The distance covered by participants during a two-minute walking test (2MWT) will be compared between RKO-assisted and shod conditions.
Step length
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
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.
Single limb support time
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
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.
Walking speed
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Mean walking speed during walking will be compared between RKO-assisted and shod conditions.
Lower limb joint kinematics
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
The sagittal plane lower limb joint angles (degrees) during walking will be compared to evaluate the difference between RKO-assisted and shod conditions.
Binary indicator of improvement in walking distance with RKO use
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
"Yes" if the walking distance in the RKO-assisted condition was greater than shod, and "No" if there was no improvement.
Lower limb electromyography data
Time frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. The study results (de-identified) will be disseminated in conference abstracts and peer-reviewed journal articles.
Related trials for Crouch Gait
Recruiting
Engaging Kids With Robotic Exoskeletons and Gamification
Genu Recurvatum, Crouch Gait
Recruiting
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Effect of Treatment on Cerebral Palsy Patient With Crouch Gait Associated With Anterior Pelvic Tilt and Soleus Muscle Weakness"Marouf Syndrome", and Muscle Assesment by Using EMG
Cerebral Palsy (CP), Diaplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RKO-assisted walking in individuals with CP in people with Crouch Gait and Cerebral Palsy (CP), run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance from 2MWT (time frame: From enrollment until data collection is performed on the fourth study session.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.