A Novel Approach to Enhance True Recovery After Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359367
• Other study ID #: 2021-05430-01
• Status: Recruiting
• Start date: November 29, 2023
• Est. completion date: June 15, 2026

Study information

• Verified date: November 2023
• Source: Danderyd Hospital
• Contact: Susanne Palmcrantz, PhD
• Phone: +46 (0)709567653
• Email: susanne.palmcrantz[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 15, 2026
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inpatients
• Observational Study
• Recovery of Function
• Stroke

Intervention

Diagnostic Test:
• Observational
Laboratory movement analysis, navigated transcranial magnetic stimulation and clinical aspects of gait function and walking.

Locations

Country	Name	City	State
Sweden	Department of Rehabilitation Medicine, Danderyd Hospital	Danderyd	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	KTH Royal Institute of Technology

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At baseline, at 3 and 6 months to assess change.
Secondary	Electromyography (EMG)	EMG is used to measure muscle activation patterns during gait.	At baseline, at 3 and 6 months to assess change.
Secondary	Neuroflexor	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.
Secondary	Modified Ashworth scale 0-5	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.
Secondary	Passive range of motion in the lower extremity	Clinical assessment of range of motion with a goniometer	At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary	The 10 meter walk test	Assesses gait speed	At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary	6 minutes walk test	Assesses walking endurance in meters walked	At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary	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.	At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary	The Functional Ambulation Categories (FAC)	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.
Secondary	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)	At baseline, weekly during inpatient rehab and at 3 and 6 months to assess change.
Secondary	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	At baseline and at 3 and 6 months to assess change.
Secondary	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.	At baseline and at 3 and 6 months to assess change.
Secondary	The Montreal Cognitive Assessment (MoCa)	Assesses mental function (0p max impairment summed up to 30p no detected impairment)	At baseline and at 3 and 6 months to assess change.
Secondary	National Institute of Health Stroke Scale	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.
Secondary	Barthel Index	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.
Secondary	Monofilament	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.
Secondary	Pain drawing	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.
Secondary	Numeric rating scale of pain	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.
Secondary	Medical Research Council scale	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.
Secondary	Walking impact scale (Walk-12)	Measures rated limitations in walking activities (1 no limitation, 5 extreme limitation)	At baseline and at 3 and 6 months to assess change