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

This study is currently recruiting participants.
Verified February 2012 by Technical University of Bern
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Clare Maguire, Technical University of Bern
ClinicalTrials.gov Identifier:
NCT01366729
First received: June 2, 2011
Last updated: February 5, 2012
Last verified: February 2012
  Purpose

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 Intervention
Stroke Gait Rehabilitation
Device: TheraTogs
Device: Cane walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Technical University of Bern:

Primary Outcome Measures:
  • Timed "up and go" test [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surface EMG of hemiplegic lower extremity musculature [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
    peak surface EMG of gluteus maximus and medius

  • temporo-spatial gait parameters [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
  • hip kinematics [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
    hemiplegic hip kinematic measurements in sagital and frontal planes

  • Dynamic balance [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
    Sway Star

  • The Stroke Impact Scale [ Time Frame: the day after intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
  • EMG activation patterns of hemiplegic leg musculature [ Time Frame: 1 day post intervention completion (max 5 weeks) ] [ Designated as safety issue: No ]
    EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior

  • Accelerometer Activity Monitoring [ Time Frame: Immediately post intervention ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366729

Contacts
Contact: Clare C Maguire, MSc PT 0041 61 417 7863 clare.maguire@bzgbs.ch

Locations
Switzerland
RehaClinic Bad Zurzach Recruiting
Zurzach, Aargau, Switzerland
Contact: Götz Hasenberg    00 41 56 269 51 51    g.hasenberg@rehaclinic.ch   
Principal Investigator: Götz Hasenberg         
Felix Platterspital Not yet recruiting
Basel, Basel-Stadt, Switzerland, 4012
Contact: Matthias Frank, MD    00 41 61 326 40 50    matthias.frank@fps-basel.ch   
Principal Investigator: Matthias Frank, MD         
Kantonsspital Luzern Recruiting
Luzern, Switzerland
Contact: Charlotte Waelti    0041 41 205 56 87    charlotte.waelti@ksl.ch   
Principal Investigator: Charlotte Waelti         
Sponsors and Collaborators
Technical University of Bern
Maastricht University
Investigators
Principal Investigator: Clare C Maguire, MSc PT Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
  More Information

No publications provided by Technical University of Bern

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clare Maguire, Principal researcher, Technical University of Bern
ClinicalTrials.gov Identifier: NCT01366729     History of Changes
Other Study ID Numbers: TTvS_13DPD6_134993_BFHBZG
Study First Received: June 2, 2011
Last Updated: February 5, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Technical University of Bern:
hemiplegia
walking
canes
TheraTogs
EMG
balance
Timed up and go

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014