Cerebral Palsy (CP)CP-AFOFCNCT03756571
Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
A study testing Ankle Foot Orthoses-Footwear Combination and Traditional Solid Ankle AFO (TSAFO) in people with Cerebral Palsy (CP), run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Ankle Foot Orthoses-Footwear Combination and Traditional Solid Ankle AFO (TSAFO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ambulatory children with spastic diplegia CP,
- spasticity primary movement disorder
- aged 4-9 years
- Gross Motor Function Classification System (GMFCS) levels of II or III
- clinically appropriate for a solid AFO based on physical exam/visual gait analysis criteria of:
- insufficient gastrocnemius length to allow knee extension with ankle dorsiflexion of 10 degrees and an uncompromised foot arch;
Show all 9Show fewer
- low tone in the calf muscles with inability to control dorsiflexion during stance;
- insufficient calf muscle strength to prevent excessive dorsiflexion in stance and create a 'quasi stiff" ankle in terminal stance that allows the heel to rise from the ground; and
- insufficient triplanar boney stability of the foot during stance phase dorsiflexion
Who cannot join
- Participants who have undergone:
- orthopedic or neurological surgery less than 6 months prior to enrollment or injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98101
About this study
Official title: Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations, AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground reaction force vector with respect to lower limb segments during gait. The AFO-FC represents a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers. The primary goal of AFO-FCs are to improve stability by facilitating more normal segment kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise, evidence of an immediate positive effect on midstance alignment is limited, with no evidence of clinical effectiveness.
This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.
Read the detailed description
The goal of this proposal is to assess the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.
Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations (e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs will optimize lower limb joint kinematics, decrease overall gait deviations facilitating longer step lengths (improved stance stability), with resultant increased gait speed as compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in joint specific kinematics with the Gait Profile Score (GPS) and overall combined gait kinematics with the GDI.
Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC will positively affect community walking activity levels, balance, physical activity and satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch ® accelerometer; balance by the Pediatric Balance Scale; physical activity by the Patient Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic Users' Survey (OPUS).
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Ankle Foot Orthoses-Footwear Combination, Traditional Solid Ankle AFO (TSAFO)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Foot Orthoses-Footwear CombinationOther
This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.
Traditional Solid Ankle AFO (TSAFO)Other
This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
| Study group | Role | What they receive |
|---|---|---|
| Ankle Foot Orthoses-Footwear Combination | Experimental | The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Receives: Other: Ankle Foot Orthoses-Footwear Combination |
| Traditional Solid Ankle AFO (TSAFO) | Active comparator | The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Receives: Other: Traditional Solid Ankle AFO (TSAFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics
The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.
Measured: 3 months post wearing assigned orthotic intervention
Change in Right Baseline Gait Deviation Index (GDI) at 3 Months
Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the normal range. A higher score is a better outcome.
Measured: 3 months post wearing assigned orthotic intervention
Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.
Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.
Measured: 3 months post wearing assigned orthotic intervention
Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.
Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.
Measured: 3 months post wearing assigned orthotic intervention
Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.
Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (> 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.
Measured: 3 months post wearing assigned orthotic intervention
Change in Left Baseline Gait Deviation Index (GDI) at 3 Months
Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the 'normal' range. A higher score is a better outcome.
Measured: Change in Right baseline Gait Deviation Index (GDI) at 3 months
Secondary outcomes (6)
Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.
The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.
Measured: 3 months post wearing assigned orthotic intervention
Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .
Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.
Measured: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.
Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score > or equal to 45 is consider Good, 36 - 44 Fair and < or equal to 35 Poor physical Function
Measured: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months
Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.
Measured: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey
Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score < 50 is considered within normal limits.
Measured: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).
Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.
Measured: 3 months post wearing assigned orthotic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start17 Dec 2018
- Primary completion28 Feb 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orthocare Innovations, Hanger Clinic: Prosthetics & Orthotics, Cascade Dafo
- Responsible party
- Principal investigator, Kristie Bjornson, Seattle Children's Hospital
- Investigators
- Kristie F Bjornson, PhD, PT, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756571
- Sponsor's protocol ID
- R21HD094823
- Acronym
- CP-AFOFC
- Status last verified
- Sep 2021
- First submitted
- 5 Nov 2018
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
- ClinicalTrials.gov ID
- NCT03756571
- Acronym / sponsor ID
- CP-AFOFC / R21HD094823
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Orthocare Innovations, Hanger Clinic: Prosthetics & Orthotics, Cascade Dafo
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations, AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground reaction force vector with respect to lower limb segments during gait. The AFO-FC represents a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers. The primary goal of AFO-FCs are to improve stability by facilitating more normal segment kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise, evidence of an immediate positive effect on midstance alignment is limited, with no evidence of clinical effectiveness.
This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.
Detailed description
The goal of this proposal is to assess the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.
Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations (e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs will optimize lower limb joint kinematics, decrease overall gait deviations facilitating longer step lengths (improved stance stability), with resultant increased gait speed as compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in joint specific kinematics with the Gait Profile Score (GPS) and overall combined gait kinematics with the GDI.
Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC will positively affect community walking activity levels, balance, physical activity and satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch ® accelerometer; balance by the Pediatric Balance Scale; physical activity by the Patient Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic Users' Survey (OPUS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.
| Arm | Type | Receives |
|---|---|---|
| Ankle Foot Orthoses-Footwear Combination | Experimental | Other: Ankle Foot Orthoses-Footwear CombinationThe intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. |
| Traditional Solid Ankle AFO (TSAFO) | Active comparator | Other: Traditional Solid Ankle AFO (TSAFO)The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- ambulatory children with spastic diplegia CP,
- spasticity primary movement disorder
- aged 4-9 years
- Gross Motor Function Classification System (GMFCS) levels of II or III
- clinically appropriate for a solid AFO based on physical exam/visual gait analysis criteria of:
Key exclusion criteria (2 listed)
- Participants who have undergone:
- orthopedic or neurological surgery less than 6 months prior to enrollment or injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment will be excluded.
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 |
|---|---|---|
| Ankle Foot Orthoses-Footwear CombinationThis is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking. | Other | Ankle Foot Orthoses-Footwear Combination |
| Traditional Solid Ankle AFO (TSAFO)This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion. | Other | Traditional Solid Ankle AFO (TSAFO) |
Primary outcome
Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics
Time frame: 3 months post wearing assigned orthotic intervention
The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.
Change in Right Baseline Gait Deviation Index (GDI) at 3 Months
Time frame: 3 months post wearing assigned orthotic intervention
Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the normal range. A higher score is a better outcome.
Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.
Time frame: 3 months post wearing assigned orthotic intervention
Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.
Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.
Time frame: 3 months post wearing assigned orthotic intervention
Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.
Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.
Time frame: 3 months post wearing assigned orthotic intervention
Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (> 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.
Change in Left Baseline Gait Deviation Index (GDI) at 3 Months
Time frame: Change in Right baseline Gait Deviation Index (GDI) at 3 months
Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the 'normal' range. A higher score is a better outcome.
6 secondary outcomes
Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.
Time frame: 3 months post wearing assigned orthotic intervention
Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .
Time frame: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.
Time frame: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months
Time frame: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey
Time frame: 3 months post wearing assigned orthotic intervention
Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).
Time frame: 3 months post wearing assigned orthotic intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kristie F Bjornson, PhD, PT principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Foot Orthoses-Footwear Combination and Traditional Solid Ankle AFO (TSAFO) in people with Cerebral Palsy (CP), run by Seattle Children's Hospital 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 9 inclusion and 2 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 14 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics (time frame: 3 months post wearing assigned orthotic intervention). The study lists 6 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 14 Oct 2021.