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| Name | Class |
|---|---|
| Multiple Sclerosis Society UK | UNKNOWN |
| NHS Lothian | OTHER_GOV |
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This investigation consists of two parallel groups of participants who will follow the same protocol. The aim of the study is to investigate the effects of using Functional Electrical Stimulation/Ankle Foot Orthosis (AFO) or splint as an assistive mobility device over a 12 week period in people with MS who experience foot drop. Patients who are clinically prescribed FES will be invited to participate in the FES arm of the study. Patients who are clinically prescribed an AFO will be invited to participate in the AFO arm. Participants will be asked to make four visits to the gait laboratory at Queen Margaret University. Four weeks before the start of device use (Baseline - 4 weeks), start of device use (Baseline), after 6 weeks and 12 weeks of device use. Participants' walking will assessed using computerised three dimensional motion analysis, which will provide a detailed description of the movements (kinematics) of the lower limbs. Participants will also be asked to carry out a 10 metre walk and a two minute walk. Both gait analysis and the walking performance tests will be carried out with and without an assistive device; apart from their first session where participants will only be assessed without their assistive device.
Participants will be asked to wear an activity monitor for 7 days after each assessment. In addition participants will be asked to complete four short standardised questionnaires (MS walking scale, MS impact scale (MSIS-29), Fatigue severity score and the Leeds MS Quality of life score) at each assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Electrical Stimulation | The Functional Electrical Stimulation (FES) group will be asked to use their clinically prescribed FES unit (either ODFS III or Pace) to the dorsiflexors to treat foot drop for a period of 12 weeks. |
| |
| Ankle Foot Orthosis | The people in the Ankle Foot Orthosis group (AFO) will be asked to use their clinically prescribed AFO to treat drop foot for a period of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electrical Stimulation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in time taken for 10 meter walk test | In the 10 meter walk test, the time taken by the participant to walk 10 meters is recorded. The test is repeated and the average is taken for analysis. | change from baseline in 10m walk test at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ankle dorsiflexion angle at initial contact | The ankle dorsiflexion angle is derived from gait analysis. The angle of the ankle at the time the foot contacts the floor during a step is derived. This is repeated for at least 5 different walks, and the average of those 5 walks is calculated for further analysis. | The change from baseline of the ankle dorsiflexion angle at initial contact from at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in distance covered in two minutes | During the 2 minute walk test the participant walks around an oval shaped track for 2 minutes. The distance covered in two minutes is taken for analysis. | The change from baseline in the the 2 minute walk test at 12 weeks. |
| The change in the MS walking scale (MSWS) |
Inclusion Criteria:
Exclusion Criteria:
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People with Multiple Sclerosis who have been prescribed either FES or an AFO to treat foot drop by their physiotherapist.
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| Name | Affiliation | Role |
|---|---|---|
| Marietta L van der Linden, PhD | Queen Margaret University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Margaret University | Musselburgh | East Lothian | EH21 6UU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25133535 | Derived | van der Linden ML, Hooper JE, Cowan P, Weller BB, Mercer TH. Habitual functional electrical stimulation therapy improves gait kinematics and walking performance, but not patient-reported functional outcomes, of people with multiple sclerosis who present with foot-drop. PLoS One. 2014 Aug 18;9(8):e103368. doi: 10.1371/journal.pone.0103368. eCollection 2014. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020427 | Peroneal Neuropathies |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Ankle Foot Orthosis | Device |
|
|
| The change from baseline in the MSWS at 12 weeks |
| the change in the MS impact scale (MSIS29) | The change from basline in the MSIS29 at 12 weeks |
| The change in the Fatigue Severity Score (FSS) | The change from baseline in the FSS at 12 weeks |
| The change in the Leeds MS Quality of Life score (LMSQoL) | The change from baseline in the LMSQoL at 12 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |