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Roads to Recovery, control of balance and gait after stroke

Completed
Conditions
Cerebro vascular accident (CVA)
Stroke
10007963
Registration Number
NL-OMON45932
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
64
Inclusion Criteria

The inclusion criteria have been specified for healthy controls and post-stroke survivors separately.
In order to be eligible to participate in the study as a healthy participant, a participant must meet the following criteria:
- No history of stroke
- Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories score 5;In order to be eligible to participate in the study as a post stroke participant , a participant must meet the following criteria: ;- Having sustain a unilateral supratentorial stroke more than 6 months ago, with mild to moderate impairments.
- Able to stand and walk independently or under supervision (Functional Ambulation Categories >= 3).
- Completed inpatient rehabilitation

Exclusion Criteria

People who meet any of the following criteria will be excluded from participation: - Conditions in which physical exercise is contra-indicated. - Unable to walk for 10 minutes without walking aid.
- Receiving physiotherapy focusing on balance or gait that cannot be cancelled during participation in this study.
- Having received perturbation-based training with visual and/or mechanical perturbations in the past year.
- Any other neurological or musculoskeletal conditions affecting balance.
- Current orthopaedic problems; hip or knee replacement, or limb amputation.
- Severe cognitive problems (Montreal Cognitive Assessment < 24).
- Persistent visuo-spatial neglect (Star-Cancellation Test <= 50) .
-Use of psychotropic drugs or other medication negatively affecting balance.
- Behavioural problems interfering with compliance to the study protocol.
- Unable to stand for 15 minutes without orthosis or walking aid.
- Pregnancy.
-Unable to give a personal consent.;Additionally, All stroke patients will be checked for eligibility for a MRI-scan. For this scan additional exclusion criteria are defined. These criteria are specified by guidelines of the Radboudumc Radiology department and are described in document F1f. MRI-controle lijst. Note, participants will still be able to participate in the study regardless of their eligibility for a MRI-scan

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main outcome of the intervention study is the proportion of individuals<br /><br>with stroke showing normalization of neuromuscular control of balance and gait<br /><br>after the intervention. This is defined as the presence of muscle synergies<br /><br>similar to a reference set of normal muscle synergies. Synergies will be<br /><br>compared pre and post training to determine the effect of DCT.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures that will be assessed are clinimetric parameters<br /><br>such as, Mini-BESTest and Trunk Impairment Scale. Cortical activity will be<br /><br>measured to determine whether there is cortical reorganization after training.<br /><br>For an additional assessment of neuromuscular structures we will determine the<br /><br>change in DMC-index pre and post intervention and will compare these to healthy<br /><br>controls as well. Furthermore, patients will have a follow-up time of 6 months<br /><br>to obtain insights in the occurrence of falls after training.</p><br>
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