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ID
Source
Brief title
Health condition
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.
Keywords:
paretic ankle muscles, ankle range of motion, ankle foot orthosis (AFO), activities, walking
NL:
parese, enkel, enkel voet orthese (EVO), bewegingsuitslag van de enkel, activiteiten, lopen
Sponsors and support
Intervention
Outcome measures
Primary outcome
During 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 outcome
Knee and hip kinetics and kinematics, measured with the GRAIL in Beatrixoord Haren.
Background summary
Rationale: 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.
Study objective
To 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.
Study design
1 day
Intervention
(1) standardized shoes + smart AFO, (2) own shoes + own AFO.
Dymphy van der Wilk
Groningen 9700 RB
The Netherlands
050 3611762
a.s.d.van.der.wilk@umcg.nl
Dymphy van der Wilk
Groningen 9700 RB
The Netherlands
050 3611762
a.s.d.van.der.wilk@umcg.nl
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5106 |
| NTR-old | NTR5238 |
| CCMO | NL48904.042.14 |
| OMON | NL-OMON41761 |