Rehabilitation After Ankle Injuries
Conditions
Brief summary
After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle support limit the range of motion in the joint, help pain relief, control loading of the injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable accurate analysis of human movement. The study is set to describe and compare the gait analysis of two modifiable stability boots (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.
Detailed description
The participants are joining one session in the gait lab. Here the are measured during walking with normal shoes and two modifiable stability boots. The duration of a session is typically 3 hours.
Interventions
DEVICEVACOped
restriction of ankle joint motion
DEVICEOrtho Tri
restriction of ankle joint motion
Sponsors
Institute for Biomechanics, ETH Zürich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy * 18-45 years old * shoe size 5,6,9 or 10
Exclusion criteria
* injuries of the lower limbs * previous surgeries on the lower limbs * neuromuscular disorders * restriction in gait capabilities * current medical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ROM Ankle Joint | duration of a session is typically 3 hours | Ankle joint motion ROM Sagittal left, during gait |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symmetrie Index | duration of a session is typically 3 hours | The symmetrie index, represents the % difference step length, index= 2\*100\*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group-VACOped-Ortho Tri-Phase All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
This group had the VACUped as first intervention. | 10 |
| Control Group-Ortho Tri-Phase-VACOped All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
This group had the Ortho Tri as first intervention. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control Group-Ortho Tri-Phase-VACOped | Total | Control Group-VACOped-Ortho Tri-Phase |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 2 | 24 years STANDARD_DEVIATION 2 | 24 years STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Switzerland | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
ROM Ankle Joint
Ankle joint motion ROM Sagittal left, during gait
Time frame: duration of a session is typically 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | ROM Ankle Joint | 31.4 degree | Standard Deviation 5.7 |
| VACOped | ROM Ankle Joint | 18.4 degree | Standard Deviation 3.5 |
| Ortho Tri-Phase | ROM Ankle Joint | 21.2 degree | Standard Deviation 3.7 |
Secondary
Symmetrie Index
The symmetrie index, represents the % difference step length, index= 2\*100\*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.
Time frame: duration of a session is typically 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Symmetrie Index | 2.45 percentage of step length | Standard Deviation 0.05 |
| VACOped | Symmetrie Index | 7.62 percentage of step length | Standard Deviation 0.15 |
| Ortho Tri-Phase | Symmetrie Index | 1.9 percentage of step length | Standard Deviation 0.04 |