Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs
Primary Purpose
Stroke Gait Rehabilitation
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
TheraTogs
Cane walking
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Gait Rehabilitation focused on measuring hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go
Eligibility Criteria
Inclusion Criteria:
- patients with hemiplegia following a first unilateral stroke
- will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact)
- must have been independent walkers prior to insult without walking aids
- Subjects will have a Mini Mental State score of 22 or above
Exclusion Criteria:
- orthopaedic or other neurological conditions that could limit walking ability
- no gross visuospatial or visual field deficits
- no medical contraindications to walking
Sites / Locations
- RehaClinic Bad Zurzach
- Felix Platterspital
- Kantonsspital Luzern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TheraTogs
Cane walking
Arm Description
Outcomes
Primary Outcome Measures
Timed "up and go" test
Secondary Outcome Measures
surface EMG of hemiplegic lower extremity musculature
peak surface EMG of gluteus maximus and medius
temporo-spatial gait parameters
hip kinematics
hemiplegic hip kinematic measurements in sagital and frontal planes
Dynamic balance
Sway Star
The Stroke Impact Scale
EMG activation patterns of hemiplegic leg musculature
EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior
Accelerometer Activity Monitoring
The accelerometer (Aipermon® GmbH, Germany) will be attached to the patient's belt and positioned above the left hip. Patients will wear the device during waking hours during intervention time. The accelerometer will be attached after dressing in the morning and only taken off for showering, bathing and sleeping. In the statistical analysis a day starts at 24.00 o'clock and ends at 23.59 o'clock the same day. Mean activity per day will be calculated
Full Information
NCT ID
NCT01366729
First Posted
June 2, 2011
Last Updated
December 28, 2022
Sponsor
Technical University of Bern
Collaborators
Maastricht University
1. Study Identification
Unique Protocol Identification Number
NCT01366729
Brief Title
Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs
Official Title
How to Improve Walking, Balance and Social Participation Following Stroke: a Comparison of Cane Walking to an Orthosis TheraTogs in Early Post-stroke Gait Rehabilitation. A Multi-centred, Single Blind,Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruite enough subjects to reach statistical power
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Bern
Collaborators
Maastricht University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability.
Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait.
To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke.
This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes.
Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation.
Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation.
Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented.The intervention will continue for five weeks or until patients have reached FAC 5 (independent walkers on all surfaces).
Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed "up and go" test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.
Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Gait Rehabilitation
Keywords
hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TheraTogs
Arm Type
Experimental
Arm Title
Cane walking
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TheraTogs
Intervention Description
Orthosis facilitating hemiplegic hip extensor and abductor activity. Worn daily from dressing in the morning to undressing at night. May be removed during therapy or afternoon sleep.
Intervention Type
Device
Intervention Name(s)
Cane walking
Intervention Description
All walking activities must take place with cane from waking until sleeping
Primary Outcome Measure Information:
Title
Timed "up and go" test
Time Frame
the day after intervention completion (max 5 weeks)
Secondary Outcome Measure Information:
Title
surface EMG of hemiplegic lower extremity musculature
Description
peak surface EMG of gluteus maximus and medius
Time Frame
the day after intervention completion (max 5 weeks)
Title
temporo-spatial gait parameters
Time Frame
the day after intervention completion (max 5 weeks)
Title
hip kinematics
Description
hemiplegic hip kinematic measurements in sagital and frontal planes
Time Frame
the day after intervention completion (max 5 weeks)
Title
Dynamic balance
Description
Sway Star
Time Frame
the day after intervention completion (max 5 weeks)
Title
The Stroke Impact Scale
Time Frame
the day after intervention completion (max 5 weeks)
Title
EMG activation patterns of hemiplegic leg musculature
Description
EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior
Time Frame
1 day post intervention completion (max 5 weeks)
Title
Accelerometer Activity Monitoring
Description
The accelerometer (Aipermon® GmbH, Germany) will be attached to the patient's belt and positioned above the left hip. Patients will wear the device during waking hours during intervention time. The accelerometer will be attached after dressing in the morning and only taken off for showering, bathing and sleeping. In the statistical analysis a day starts at 24.00 o'clock and ends at 23.59 o'clock the same day. Mean activity per day will be calculated
Time Frame
Immediately post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with hemiplegia following a first unilateral stroke
will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact)
must have been independent walkers prior to insult without walking aids
Subjects will have a Mini Mental State score of 22 or above
Exclusion Criteria:
orthopaedic or other neurological conditions that could limit walking ability
no gross visuospatial or visual field deficits
no medical contraindications to walking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare C Maguire, MSc PT
Organizational Affiliation
Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
Official's Role
Principal Investigator
Facility Information:
Facility Name
RehaClinic Bad Zurzach
City
Zurzach
State/Province
Aargau
Country
Switzerland
Facility Name
Felix Platterspital
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4012
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzern
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22462692
Citation
Maguire C, Sieben JM, Erzer F, Goepfert B, Frank M, Ferber G, Jehn M, Schmidt-Trucksass A, de Bie RA. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial. BMC Neurol. 2012 Mar 30;12:18. doi: 10.1186/1471-2377-12-18.
Results Reference
derived
Learn more about this trial
Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs
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