Feasibility, functionality and comfort of a novel concept Ankle-Foot-Orthosis for equinus foot

Feasibility, functionality and comfort of a novel concept Ankle-Foot-Orthosis for equinus foot - A novel AFO concept

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52812

Enrollment

Registered

2019-12-19

Start date

2021-02-18

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

equinus foot spastic foot deformity

Interventions

Application of the new AFO in single joint measurements using an instrumented ankle manipulator and during gait using standard instrumented gait analysis, electromyography (EMG) and accelerometry .

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) a. Chronic stroke phase (defined as first stroke > 6 months) b. Traumatic Brain Injury (> 6 months) c. Hypoxic Brain Injury (> 6 months) d. Cerebral Palsy e. Multiple Sclerosis (relapse free in the previous 3 months) f. Chronic incomplete spinal cord injury (> 6 months, ASIA score C or D) 2) Spastic paresis of the triceps surea muscles of the right or left leg a. MAS>=2 (n=5) b. MAS not restricted (n=25) 3) Equinus or equinovarus foot deformity of the affected spastic side (as mentioned under criteria no. 2), defined as an increased passive ankle joint stiffness and limited active range of motion of the affected side compared to the non-affected side 4) Prescribed walking aid (orthotic shoes or AFO)

Exclusion criteria

Exclusion criteria: 1) Age

Design outcomes

Primary

Measure	Time frame
Active RoM at single joint level and during gait are primary outcomes.	—

Secondary

Measure	Time frame
Comfort and walkability based on PROMs and from instrumented gait analysis are secondary outcomes.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)