A Novel Approach to Enhance True Recovery After Stroke

December 3, 2025 updated by: Danderyd Hospital

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Stockholm County
      • Danderyd, Stockholm County, Sweden, SE-18288
        • Department of Rehabilitation Medicine, Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motion analysis during gait
Time Frame: At baseline, at 3 and 6 months to assess change.
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.
At baseline, at 3 and 6 months to assess change.
Electromyography (EMG)
Time Frame: At baseline, at 3 and 6 months to assess change.
EMG is used to measure muscle activation patterns during gait.
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.
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
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.
Clinical assessment of range of motion with a goniometer
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.
Assesses gait speed
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.
Assesses walking endurance in meters walked
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.
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test.
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.
Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
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.
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)
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.
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
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.
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
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.
To assess overall effects of stroke (ranging from 0-44 points, a higher score indicating more severe disability).
At baseline and at 3 and 6 months to assess change.
Neuroflexor
Time Frame: At baseline, at 3 and 6 months to assess change.
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
At baseline, 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.
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.
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.
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
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.
Measuring cutaneous sensory perception threshold under foot with a pressure of 4, 6 and 10 grams.
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.
Self-assessed location and type of pain on the body
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.
Self-rated general intensity of pain at time of assessment (0 no pain, 10 worst imaginable pain)
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.
Assesses movement strength at a specific joint and motion (0 no muscle activity 5 normal force)
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
Measures rated limitations in walking activities (1 no limitation, 5 extreme limitation)
At baseline and at 3 and 6 months to assess change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danderyd Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KTH Royal Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susanne M Palmcrantz, PhD, Dep of Clinical Sciences, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-05430-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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