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Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs

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ClinicalTrials.gov Identifier: NCT01366729
Recruitment Status : Terminated (Unable to recruite enough subjects to reach statistical power)
First Posted : June 6, 2011
Last Update Posted : December 29, 2022
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Clare Maguire, Technical University of Bern

Study Description
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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


Condition or disease Intervention/treatment Phase
Stroke Gait Rehabilitation Device: TheraTogs Device: Cane walking Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: TheraTogs Device: TheraTogs
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.
Active Comparator: Cane walking Device: Cane walking
All walking activities must take place with cane from waking until sleeping


Outcome Measures
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Primary Outcome Measures :
  1. Timed "up and go" test [ Time Frame: the day after intervention completion (max 5 weeks) ]

Secondary Outcome Measures :
  1. surface EMG of hemiplegic lower extremity musculature [ Time Frame: the day after intervention completion (max 5 weeks) ]
    peak surface EMG of gluteus maximus and medius

  2. temporo-spatial gait parameters [ Time Frame: the day after intervention completion (max 5 weeks) ]
  3. hip kinematics [ Time Frame: the day after intervention completion (max 5 weeks) ]
    hemiplegic hip kinematic measurements in sagital and frontal planes

  4. Dynamic balance [ Time Frame: the day after intervention completion (max 5 weeks) ]
    Sway Star

  5. The Stroke Impact Scale [ Time Frame: the day after intervention completion (max 5 weeks) ]
  6. EMG activation patterns of hemiplegic leg musculature [ Time Frame: 1 day post intervention completion (max 5 weeks) ]
    EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior

  7. Accelerometer Activity Monitoring [ Time Frame: Immediately post intervention ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366729


Locations
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Switzerland
RehaClinic Bad Zurzach
Zurzach, Aargau, Switzerland
Felix Platterspital
Basel, Basel-Stadt, Switzerland, 4012
Kantonsspital Luzern
Luzern, Switzerland
Sponsors and Collaborators
Technical University of Bern
Maastricht University
Investigators
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Principal Investigator: Clare C Maguire, MSc PT Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clare Maguire, Principal researcher, Technical University of Bern
ClinicalTrials.gov Identifier: NCT01366729    
Other Study ID Numbers: TTvS_13DPD6_134993_BFHBZG
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
Keywords provided by Clare Maguire, Technical University of Bern:
hemiplegia
walking
canes
TheraTogs
 EMG
balance
Timed up and go
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases