Clinical trial NCT05359367: A Novel Approach to Enhance True Recovery After Stroke
Official title: A Novel Approach to the Development of New Treatment Strategies to Enhance True Recovery After Stroke, Based on Laboratory Movement Analysis and Clinical Aspects of Gait Function and Walking
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Inpatients
Recovery of Function
Observational Study
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: KTH Royal Institute of Technology
First posted: 2022-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients will have suffered a stroke, verified by CT or MRI examination and are admitted to inpatient care at the University Department of Rehabilitation Medicine Danderyd Hospital.

Brief summary: The purpose of this study is to elucidate pathophysiological mechanisms behind gait disturbances during the early recovery phase after hemiparetic stroke to identify targets for new treatment strategies.

Using an explorative, observational study design, pathophysiological mechanisms at play during the early recovery phase will be monitored, by repeated clinical assessments during inpatient rehabilitation as well as examinations of muscle activation patterns, kinematics of walking, corticospinal and reticulospinal function \< 1 month, 3 and 6 months after hemiparetic stroke.

Inclusion: Eligible patients will have suffered a stroke, verified by CT or MRI examination and are admitted to inpatient care at the University Department of Rehabilitation Medicine Danderyd Hospital (RUDS). Thirty patients will be included consecutively. With an anticipated loss of 4-10 patients, at least 20 are expected to complete the study.

The clinical assessment protocols include standardized measures for the assessment of clinical and self-perceived aspects of functioning and disability. These assessments will be performed and repeated \< 1 month, at 3 months and 6 months post-stroke by a therapist not responsible for rehabilitation interventions. At each of these assessment instances, laboratory movement analysis including electromyography (EMG) and ultrasound of the lower extremity muscle will be performed. In addition, a short assessment of body function and activity will be performed weekly during inpatient rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Participants with hemiplegia, dependence in ambulation (1- 4 according to the Functional Ambulation Categories (FAC)),
* \>= 50 points on the Trunk Control Test.
* Impaired dorsiflexion manifested as impaired voluntarily dorsiflexion and inability to hold the ankle in a dorsiflexed position while sitting, and for ambulatory participants, impaired dorsiflexion during swing phase and initial contact during visual inspection of gait.
* Recommended for an ancle foot orthosis (AFO) by an experienced physiotherapist. Able to understand study information and provide informed consent.

Exclusion Criteria:

* Contracture that severely restricts gait movements in a lower limb joint,
* cardiovascular or other somatic condition incompatible with intensive gait training,
* notifiable infectious disease, contagious infections (e.g. MRSA or ESBL)
* Inability to participate in the rehabilitation intervention due to behavioral or psychiatric disorder
* when magnetic resonance imaging will be performed, additional exclusion criteria are current or history of epilepsy, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal and infusion device.

Primary outcomes:
measure: Fugl-Meyer score (FMA-LE)
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary outcomes:
measure: Motion analysis during gait
timeFrame: At baseline, at 3 and 6 months to assess change.
measure: Electromyography (EMG)
timeFrame: At baseline, at 3 and 6 months to assess change.
measure: Neuroflexor
timeFrame: At baseline, at 3 and 6 months to assess change.
measure: Modified Ashworth scale 0-5
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Passive range of motion in the lower extremity
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: The 10 meter walk test
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: 6 minutes walk test
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Rated Perceived Exertion (RPE) Scale
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: The Functional Ambulation Categories (FAC)
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: The Balance evaluation systems test (BEST-test)
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Falls Efficacy Scale (FES-S)
timeFrame: At baseline and at 3 and 6 months to assess change.
measure: Navigated Transcranial magnetic stimulation (nTMS)
timeFrame: At baseline and at 3 and 6 months to assess change.
measure: The Montreal Cognitive Assessment (MoCa)
timeFrame: At baseline and at 3 and 6 months to assess change.
measure: National Institute of Health Stroke Scale
timeFrame: At baseline and at 3 and 6 months to assess change.
measure: Barthel Index
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Monofilament
timeFrame: At baseline, at 3 and 6 months to assess change.
measure: Pain drawing
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Numeric rating scale of pain
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Medical Research Council scale
timeFrame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
measure: Walking impact scale (Walk-12)
timeFrame: At baseline and at 3 and 6 months to assess change
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
affiliation: Dep of Clinical Sciences, Karolinska Institutet
name: Susanne M Palmcrantz, PhD
role: PRINCIPAL_INVESTIGATOR
References: