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Evaluation of a smart ankle foot orthosis


- candidate number22244
- NTR NumberNTR5238
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2015
- Secondary IDsNL48904.042 ABR number
- Public TitleEvaluation of a smart ankle foot orthosis
- Scientific TitlePilot study of a smart ankle foot orthosis in people with paretic ankle muscles.
- ACRONYMEvaluation of a smart ankle foot orthosis
- hypothesisTo evaluate if the smart AFO provides adequate ankle moments and allows normal ankle range of motion during walking and to evaluate if the execution of activities improves when using the smart AFO.
- Healt Condition(s) or Problem(s) studiedParese, Ankle, Physical activity
- Inclusion criteria- Aged ≥18 years
- Able to understand Dutch
- Plantar flexor paresis (MRC-scale ≤3) (MRC is muscle strength from 0-5)
- Able to walk for a minimum of 6 minutes with own orthosis with or without additional walking aids
- Shoe size between 36 and 46
- Unilateral or bilateral plantar flexor paresis
- Use of an AFO daily (minimum 2 hrs/day, 6 days/week)
- Minimum ankle ROM of 15° (0-5° dorsiflexion, 10-15° plantarflexion)
- K-level 2 and higher
- Exclusion criteria- Diabetes
- Spasticity of the lower extremity muscles
- Using additional lower extremity orthosis (excluding insoles)
- Unable to complete the tests (total 2:30hrs)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-mei-2015
- planned closingdate
- Target number of participants10
- Interventions(1) standardized shoes + smart AFO, (2) own shoes + own AFO.
- Primary outcomeDuring level and hill walking (7° inclination and 7° declination), measured with the GRAIL in Beatrixoord Haren:
a. Heel rocker:
i. Angular velocity of the ankle
ii. Ankle moment
iii. Ankle motion
iv. Ankle power
v. Duration of the heel rocker
b. Ankle rocker:
i. Ankle motion
ii. Ankle moment
iii. Ankle power
iv. Duration of the ankle rocker
c. Forefoot rocker:
i. Ankle motion
ii. Ankle moment
iii. Ankle power
iii. Duration of the forefoot rocker
d. Swing phase:
i. Ankle motion
ii. Duration of the swing phase
Time to perform activities, measured with a stopwatch:
- Timed Up and Go Test
- Timed three steps Stairs Ascent Test
- Timed three steps Stairs Descent Test
- Five Times Sit To Stand Test
Subject experience with the AFOs and suggestions for improvement measured with a self-developed questionnaire.
- Secondary outcomeKnee and hip kinetics and kinematics, measured with the GRAIL in Beatrixoord Haren.
- Timepoints1 day
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Dymphy van der Wilk
- CONTACT for SCIENTIFIC QUERIES Dymphy van der Wilk
- Sponsor/Initiator Research center SPRINT, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), SNN (grant number T1015), Northern Netherlands Provinces Alliance
- Publications
- Brief summaryRationale: Patients with paretic ankle muscles often use ankle foot orthosis (AFO) to improve walking. However, current AFOs also prevent ankle range of motion (ROM) and diminishes intact ankle muscle activity, thereby hampering the execution of activities in which ankle ROM is needed. Examples of such activities are level walking, hill locomotion, stair locomotion and standing up from/ sitting down on a chair. A smart AFO was designed to take over impaired ankle muscle activity and allow normal ankle ROM during level walking and during the execution of specific activities.
Objective: To evaluate if the smart AFO provides adequate ankle moments and allows normal ankle ROM during level walking and during the execution of specific activities. Study design: Feasibility study with cross-over design and random sequence generation.
Study population: Ten adults with plantarflexor paresis with or without dorsiflexor paresis.
Interventions: (1) standardized shoes + smart AFO, (2) own shoes + own AFO.
Study parameters/endpoints: Ankle moments and motion during stance phase and ankle motion during swing phase of level and hill walking. Timed performance of the timed up and go test, timed up and down stairs and timed sit to stand test. Subject experiences with the orthotic devices will be measured using a self-developed questionnaire. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only immediate effects of the orthotic devices will be measured. Time span for a subject will be 2:30hrs. Subjects will walk at a self-selected speed on a treadmill that is also used for regular training purposes. Besides level and hill walking (both on the same treadmill), subjects walk up and down a three steps standardized staircase and stand up from/ sit down on a standardized chair. The smart AFO should improve both patients´ gait and the execution of activities.
- Main changes (audit trail)
- RECORD28-mei-2015 - 15-aug-2015


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