The impact of training to improve patients' condition after ischemic stroke
| ISRCTN | ISRCTN16891871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16891871 |
- Submission date
- 22/04/2022
- Registration date
- 20/05/2022
- Last edited
- 20/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. New methods of physiotherapy are being used with patients after a stroke based on the natural mechanisms of reorganization of the nervous system. The aim of this study is to demonstrate the activating effect of physical effort on the nervous, muscular and vascular tissue in patients after an ischemic stroke.
Who can participate?
Patients aged 45-65 years who have had an ischemic stroke
What does the study involve?
Patients will be assigned to three groups: patients with upper limb hemiparesis treated with mirror therapy (MT), patients rehabilitated by the method of proprioceptive neuromuscular facilitation (PNF), and patients with upper limb hemiparesis practised using the traditional method (they will be treated as the control group). Each patient is treated for 6 weeks (36 days from Monday to Saturday). Each patient also participates 5 days a week in occupational therapy (30 minutes a day), in therapy with a psychologist (30 minutes a day) and with a neurologopedist (30 minutes a day). Various blood tests will be carried out at the start of the study and at 14, 28, and 42 weeks (every 2 weeks during rehabilitation in the ward and after its completion in the 6th week).
What are the possible benefits and risks of participating?
Participants may benefit from the use of modern methods of physiotherapy after stroke and the supervision of specialist personnel for 6 weeks. Risks associated with the blood sampling procedure include weakness (especially during the first blood loss), infections, vein and artery damage, nerve damage, tendon injuries, and local allergic reactions.
Where is the study run from?
Regional Specialist Hospital in Wrocław, Local Department of Neurological Rehabilitation (Wroclaw, Poland)
When is the study starting and how long is it expected to run for?
December 2020 to December 2023
Who is funding the study?
Wroclaw University of Health and Sport Sciences (Poland)
Who is the main contact?
Mr Wojciech Borowicz
wojtekborowka@interia.pl
Contact information
Principal Investigator
Department of Nervous System Diseases
Department of Clinical Nursing
Medical University of Wroclaw
Bartla 5 Street
Wroclaw
51-618
Poland
| Phone | +48 (0)71 784 18 04 |
|---|---|
| wojtekborowka@interia.pl |
Study information
| Study design | Open-label non-randomized controlled interventional clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The impact of training to improve the condition patients after ischemic stroke on the level of selected growth factors and neuronal, muscle, and vascular plasticity |
| Study acronym | TIPS |
| Study hypothesis | The main goal of the research will be to demonstrate the activating effect of physical effort on the plasticity of nervous, muscular, and vascular tissue in patients after ischemic stroke. Tissue plasticity will be examined indirectly based on the degree of changes in the concentrations of BDNF (brain-derived neurotrophic factor) and other nerve growth factors - NGF (nerve growth factor), NT-3 (neurotrophin -3), blood vessels - VEGF (vascular endothelial growth factor), factors stimulating the proliferation of muscle satellite cells - HGF (hepatocyte growth factor) and IGF (insulin-like growth factor), released into the blood during various forms of rehabilitation training in people after ischemic stroke. For this purpose, mirror therapy, proprioceptive neuromuscular facilitation (PNF), and the traditional method will be used. The research will show whether the factors responsible for neuronal, muscular, and vascular plasticity are secreted during the rehabilitation of patients after ischemic stroke and whether their secretion correlates with ischemic changes and their extent, and with therapeutic effects. |
| Ethics approval(s) | Approved 14/12/2020, Institutional Review Board at Wroclaw Medical University (ul. Pasteura 1, 50-367 Wrocław, Poland; +48 71 784 17 10; bioetyka@umed.wroc.pl), ref: KB – 813/2020 |
| Condition | Ischemic stroke |
| Intervention | Patients qualified by the doctor to the study group before each unit of rehabilitation training had heart rate (HR) and blood pressure (RR) measurements. Improvement training has always been selected individually for each patient to their current physical abilities and needs. Its intensity was analyzed based on HR, measured with a sportester. At the same time, HR was current information characterizing the patient's emotional state and the level of fatigue. Patients will be assigned to three groups: 1. Patients with upper limb hemiparesis treated with mirror therapy (MT): Exercises performed twice a day for 30 minutes. The patient was sitting at a table with a mirror supported vertically on the side of the paresis half of the body. In such a way that the involved upper limb rested on the table behind the mirror and the healthy one in front of the mirror. The examined person tried to make symmetrical movements with both upper limbs according to the order of the researcher - moving the involved upper limb behind the mirror as best they could, starting with the easiest movements to make. The order of performing individual tasks was individually adjusted depending on the functional abilities of the examined person. The examined person was constantly watching the mirror image of the movement of the healthy hand in the mirror, which gave the impression that the involved upper limb was moving correctly. The patients were treated with kinesiotherapy (standard care rehabilitation program - active and passive exercises of the paresis limb, active exercises to relieve the paresis limb, balance exercises, coordination exercises, breathing exercises) for 6 days a week, 1 hour a day. Each patient was treated for 6 weeks (36 days from Monday to Saturday). Each patient participated 5 days a week in occupational therapy (30 minutes a day), in therapy with a psychologist (30 minutes a day) and with a neurologopedist (30 minutes a day). 2. Patients rehabilitated by the method of proprioceptive neuromuscular facilitation (PNF): The physiotherapy program was selected individually to the patient's abilities. The duration of the PNF therapy was 1 hour a day. The following main principles of PNF were used: therapist body mechanics, contact: manual, verbal and visual, optimal resistance, irradiation, approximation, and PNF techniques: rhythmic initiation of movement, combination of isotonic contractions, dynamic continuous maneuver, feedback stabilization, restoration of movement. PNF patterns were used: for work on the trunk: posterior depression of the scapula, front elevation of the scapula, front elevation of the pelvis, posterior pelvic depression, combinations of scapula and pelvis patterns (shortening of the elongation of the trunk with rotation), chopping - bilateral, asymmetric bend of the upper limbs with neck flexion, bilateral flexion patterns of the lower limbs with flexion of the knee joints, scooting - walking on the buttocks, rocking - moving the pelvis forwards and backwards. For work on the upper limb: flexion - abduction - external rotation, extension - abduction - internal rotation. For work on the lower limb: directly affected side: flexion - abduction - internal rotation with knee flexion, to the transfer phase flexion - adduction - external rotation, to the stance phase: extension - abduction - internal rotation. The patients were treated with kinesiotherapy (standard care rehabilitation program - active and passive exercises of the paresis limb, active exercises to relieve the paresis limb, balance exercises, coordination exercises, breathing exercises) for 6 days a week, 1 hour a day. Each patient was treated for 6 weeks (36 days from Monday to Saturday). Each patient participated 5 days a week in occupational therapy (30 minutes a day), in therapy with a psychologist (30 minutes a day) and with a neurologopedist (30 minutes a day). 3. Patients with upper limb hemiparesis - practiced using the traditional method, treated as the control group (K): The patients were treated with kinesiotherapy (standard care rehabilitation program - active and passive exercises of the paresis limb, active exercises to relieve the paresis limb, balance exercises, coordination exercises, breathing exercises) for 6 days a week, 1 hour a day. Each patient was treated for 6 weeks (36 days from Monday to Saturday). Each patient participated 5 days a week in occupational therapy (30 minutes a day), in therapy with a psychologist (30 minutes a day) and with a neurologopedist (30 minutes a day). |
| Intervention type | Behavioural |
| Primary outcome measure | The concentrations of BDNF, IGF-1, HGF, NT-3, NGF, VEGF, serotonin, lactate, dopamine, and cortisol from the blood serum at baseline, 14, 28, and 42 weeks (every 2 weeks during rehabilitation in the ward and after its completion, in the 6th week). Each patient will have blood drawn four times. |
| Secondary outcome measures | 1. Everyday activities assessed using the Barthel Scale at baseline, 14, 28, and 42 weeks 2. Ability to perform complex everyday activities assessed using the Instrumental Activities of Daily Living Scale (IADL Scale) at baseline, 14, 28, and 42 weeks 3. Hand dexterity assessed using the Frenchay hand test (Frenchay Arm Test) at baseline, 14, 28, and 42 weeks 4. Degree of depression assessed using the Anxiety and Depression Scale (HADS Scale) at baseline, 14, 28, and 42 weeks |
| Overall study start date | 01/12/2020 |
| Overall study end date | 01/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 90 patients (30 per group) |
| Participant inclusion criteria | 1. Consent to participate in the trial 2. 45-65-year-old patients who suffered an ischemic stroke 3. In the regeneration and compensation period after a stroke 4. Patients admitted for early post-stroke rehabilitation |
| Participant exclusion criteria | 1. Complete lack of movement of the upper limb 2. Very fit upper limb 3. Time from stroke longer than 30 days 4. Complete lack of cooperation on the part of the patient (global aphasia, lack of patient consent) 5. Complete stiffening of the shoulder joint |
| Recruitment start date | 01/01/2021 |
| Recruitment end date | 01/09/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Poświecka 8 Street
Wroclaw
51-128
Poland
Sponsor information
University/education
al. Ignacego Jana Paderewskiego 35
Wroclaw
51-612
Poland
| Phone | +48 (0)71 347 33 60 |
|---|---|
| dzial.nauki@awf.wroc.pl |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from Mr Wojciech Borowicz (wojtekborowka@interia.pl) on reasonable request. Raw data (taking into account the anonymity of patients) will become available from the end of the study for 5 years. The research results will be passed on to other researchers in order to compare these results with the results of their own research. |
Editorial Notes
26/04/2022: Trial's existence confirmed by the Institutional Review Board at Wroclaw Medical University.
