A Novel Approach to Enhance True Recovery After Stroke

NCT05359367 | Terminated

• 1 other identifier: 2021-05430-01
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Inpatients; Recovery of Function; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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)

  At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.

Secondary Outcomes (20)

• Motion analysis during gait

  At baseline, at 3 and 6 months to assess change.

• Electromyography (EMG)

  At baseline, at 3 and 6 months to assess change.

• Neuroflexor

  At baseline, at 3 and 6 months to assess change.

• Modified Ashworth scale 0-5

  At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.

• Passive range of motion in the lower extremity

  At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.

Interventions

Observational DIAGNOSTIC_TEST

Laboratory movement analysis, navigated transcranial magnetic stimulation and clinical aspects of gait function and walking.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danderyd Hospital: lead
• KTH Royal Institute of Technology: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE-18288, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susanne M Palmcrantz, PhD

  Dep of Clinical Sciences, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: November 29, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)