StrokeNCT05359367
A Novel Approach to Enhance True Recovery After Stroke
An observational study of Stroke and Inpatients, run by Danderyd Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Inpatients, Recovery of Function
- What is being tested?
- Observational
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2023to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE-18288
About this study
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
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.
Read more
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.
- Conditions
- Stroke, Inpatients, Recovery of Function, Observational Study
- Being tested
- Observational
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDiagnostic test
Laboratory movement analysis, navigated transcranial magnetic stimulation and clinical aspects of gait function and walking.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer score (FMA-LE)
Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary outcomes (20)
Motion analysis during gait
In a movement laboratory (Vicon V16), data for motion analysis will be collected by assessing orientation of body segments and joint angle trajectories and forces by means of force plates (AMTI) during walking.
Measured: At baseline, at 3 and 6 months to assess change.
Electromyography (EMG)
EMG is used to measure muscle activation patterns during gait.
Measured: At baseline, at 3 and 6 months to assess change.
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Measured: At baseline, at 3 and 6 months to assess change.
Modified Ashworth scale 0-5
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Passive range of motion in the lower extremity
Clinical assessment of range of motion with a goniometer
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The 10 meter walk test
Assesses gait speed
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
6 minutes walk test
Assesses walking endurance in meters walked
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Rated Perceived Exertion (RPE) Scale
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test.
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The Functional Ambulation Categories (FAC)
Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The Balance evaluation systems test (BEST-test)
Assesses postural control, incorporating bio-mechanical systems, limits of stability, anticipatory postural adjustment, automatic postural responses, sensory orientation, stability in gait (0p max impairment summed up to 108p no impairment)
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Falls Efficacy Scale (FES-S)
Assesses self perceived balance in every day life activities rated on a 11 point scale (0p not safe at all 10p completely safe). Total score: 0- 130 p
Measured: At baseline and at 3 and 6 months to assess change.
Navigated Transcranial magnetic stimulation (nTMS)
To estimate the integrity of the corticospinal tract, transcraniel magnetic stimulation will be applied to the primary motor cortex and motor evoked potentials will be will be recorded from the lower leg muscles using electromyography.
Measured: At baseline and at 3 and 6 months to assess change.
The Montreal Cognitive Assessment (MoCa)
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Measured: At baseline and at 3 and 6 months to assess change.
National Institute of Health Stroke Scale
To assess overall effects of stroke (ranging from 0-44 points, a higher score indicating more severe disability).
Measured: At baseline and at 3 and 6 months to assess change.
Barthel Index
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Monofilament
Measuring cutaneous sensory perception threshold under foot with a pressure of 4, 6 and 10 grams.
Measured: At baseline, at 3 and 6 months to assess change.
Pain drawing
Self-assessed location and type of pain on the body
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Numeric rating scale of pain
Self-rated general intensity of pain at time of assessment (0 no pain, 10 worst imaginable pain)
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Medical Research Council scale
Assesses movement strength at a specific joint and motion (0 no muscle activity 5 normal force)
Measured: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Walking impact scale (Walk-12)
Measures rated limitations in walking activities (1 no limitation, 5 extreme limitation)
Measured: At baseline and at 3 and 6 months to assess change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start29 Nov 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Why it stopped: Due to low recruitment and follow up rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KTH Royal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Susanne M Palmcrantz, PhD, Principal investigator, Dep of Clinical Sciences, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359367
- Sponsor's protocol ID
- 2021-05430-01
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05359367
- Acronym / sponsor ID
- 2021-05430-01
- Conditions
- Stroke, Inpatients, Recovery of Function, Observational Study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to low recruitment and follow up rate.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- KTH Royal Institute of Technology
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalLaboratory movement analysis, navigated transcranial magnetic stimulation and clinical aspects of gait function and walking. | Diagnostic test | – |
Primary outcome
Fugl-Meyer score (FMA-LE)
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
20 secondary outcomes
Motion analysis during gait
Time frame: At baseline, at 3 and 6 months to assess change.
Electromyography (EMG)
Time frame: At baseline, at 3 and 6 months to assess change.
Neuroflexor
Time frame: At baseline, at 3 and 6 months to assess change.
Modified Ashworth scale 0-5
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Passive range of motion in the lower extremity
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The 10 meter walk test
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
6 minutes walk test
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Rated Perceived Exertion (RPE) Scale
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The Functional Ambulation Categories (FAC)
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
The Balance evaluation systems test (BEST-test)
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Falls Efficacy Scale (FES-S)
Time frame: At baseline and at 3 and 6 months to assess change.
Navigated Transcranial magnetic stimulation (nTMS)
Time frame: At baseline and at 3 and 6 months to assess change.
The Montreal Cognitive Assessment (MoCa)
Time frame: At baseline and at 3 and 6 months to assess change.
National Institute of Health Stroke Scale
Time frame: At baseline and at 3 and 6 months to assess change.
Barthel Index
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Monofilament
Time frame: At baseline, at 3 and 6 months to assess change.
Pain drawing
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Numeric rating scale of pain
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Medical Research Council scale
Time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Walking impact scale (Walk-12)
Time frame: At baseline and at 3 and 6 months to assess change
Results and safety
The study was stopped early (reason given: Due to low recruitment and follow up rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Palmcrantz, PhD principal investigator
Dep of Clinical Sciences, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Inpatients, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to low recruitment and follow up rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer score (FMA-LE) (time frame: At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.