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Trial registered on ANZCTR


Registration number
ACTRN12619000110189
Ethics application status
Approved
Date submitted
7/01/2019
Date registered
24/01/2019
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of combined lower limb therapy on selected structural parameters, activity and quality of life in people after stroke.
Scientific title
The influence of one year combined lower limb therapy on clinical tests stabilometric platform and quality of life in people after stroke.
Secondary ID [1] 296975 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 310936 0
spasticity 310937 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309601 309601 0 0
Physiotherapy
Stroke 309602 309602 0 0
Ischaemic
Stroke 309603 309603 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One cycle of combination therapy will last for 6 weeks. After completing the first stage, patients will be qualified to participate in the next cycle of therapy. Between the successive stages there will be a break of 9 weeks. Patients qualified to participate in the program will take part in three such cycles. The total time of participation in the study will be 12 months. Therapeutic management will be carried out by a multidisciplinary team of doctors and physiotherapists. Treatment consisted of the procedure will be described below multifactorial as "combination therapy." To monitor adherence it will be used register of attendance at injection and exercise sessions.
Combination therapy of lower limb will consist of the following interactions;
1. Injection preparation of botulinum toxin type A (intramuscular injection)
2. Movement Therapy

Patients will be injected with Botulinum toxin a three times over a period of 12 months. In controlled clinical trials, patients are administered a dose of the product in the dimension of 100 units. The muscles chosen to receive botox and the dose delivered to each of those muscles is determined at the clinical discretion of the treating neurologist based on severity of symptoms in each muscle. They will be divided between the occupied muscle groups and served during one procedure under the control of ultrasound.
The drug will be administered in muscle (intramuscular injection):
a) gastrocnemius muscle, medial head (75 units)
b) calf muscle, lateral head (75 units)
c) soleus muscle (75 units)
d) tibialis posterior (75 units)
Injections will always be made by the specialist neurologist at the clinical discretion of the treating neurologist based on severity of symptoms in each muscle.
Eligible patients for the research program will be submitted to 3 administrations of botox. Each time, after 3 weeks after each botox administration, patients will take part in the ongoing three weeks of individual therapeutic exercise program (3 weeks x 5 days per week x 60 minutes) at the study site at The University of Physical Education. Study participants will be evaluated clinically at the time they qualify for each of the three stages of the research program and after completion of each. During the 3 weeks movement therapy, participants will be required to attend physical therapy 5 days a week. Each session will be lasted 60 minutes.
The first part of the training program consists of a short 10 minute warm-up of simple whole body exercises (marching, arm swings, standing with hands on knees making circular movements) followed by gentle stretching exercises (e.g., calf muscle stretch, hamstring muscle stretch, thigh muscle stretch, trunk side stretch). After the warm-up, the major components address for example: functional strengthening, balance and agility exercises, cardiovascular exercises and transfer.

Functional strengthening involves tasks that address muscle weakness through repetitive coordinated movements that challenge lower limb muscles. Altered motor coordination is evident following a stroke and improvements in movements can be accomplished by utilizing functional movements and postures under challenging conditions. Thus, most of the functional strengthening exercises are done in standing which has advantages in forcing weight-bearing and muscle activity through the limb affected by the stroke. Balance and agility exercises include slow and fast movements. It stimulates the centre of mass to be moved to extents over the base of support. Faster movements (e.g, quick step in different directions) improve the rate of voluntary movement and the ability to weight-bear on the paretic limb.

Another component focuses on aerobic fitness. Many activities overlap into all of these components. For example, fast walking and walking with longer than usual steps were used as part of the aerobic component, but these tasks will also strengthen plantarflexor and hip flexor muscle activity, in addition to agility. Lastly, a short cool-down can replicate some of the stretching performed during the warm-up.. It will be individual sessions with physiotherapist.The program will be adapted to the individual needs and capabilities of each patient.
Intervention code [1] 313247 0
Rehabilitation
Intervention code [2] 313248 0
Treatment: Drugs
Comparator / control treatment
Participants will undergo a clinical evaluation 3 weeks prior to the first cycle of combination therapy. This will allow to check the spontaneous changes in the parameters assessed and create a "control group" within the patients qualified for the project.
Control group
Active

Outcomes
Primary outcome [1] 318562 0
Stability, assessed using stabilometric platform
Timepoint [1] 318562 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.
Primary outcome [2] 318563 0
Spasticity symptom severity, assessed using Medical research council scale
Pternostro-Sluga T, Grim-Stieger M, Posch M, Schuhfried O, Vacariu G, Mittermaier C, Bittner C, Fialka-Moser V. Reliability and validity of Medical Research Council (MRC) scale for testing strength in patients with radial palsy. J Rehabil Med. 2008 Aug;40(8):665-71
Timepoint [2] 318563 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.
Primary outcome [3] 318564 0
Spasticity symptom severity assessed using Modified Ashworth Scale
Timepoint [3] 318564 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.
Secondary outcome [1] 365381 0
Trunk and lower limb functionalities - Rivermed Motor Assesment (composite)
Timepoint [1] 365381 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.
Secondary outcome [2] 365382 0
10 Meter Walk test
Timepoint [2] 365382 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.
Secondary outcome [3] 365383 0
Quality of life - Stroke Impact Scale
Timepoint [3] 365383 0
The outcome assessed at the time of qualifying patients for the research project and after 12 months.

Eligibility
Key inclusion criteria
a) aged grater than 50 less than 65,
b) after ischemic stroke in a period of at least 3 months before inclusion in the program, and no later than 5 years after the stroke,
c) confirmed post-traumatic spasticity of the lower limb - moderate or higher degree (result in the modified Ashworth scale MAS equal to or greater than 2)
d) capable of independent passage of 20 m (only orthopedic supplies in the form of an AFO or DAFO orthosis are allowed).
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) severe dysphagia or respiratory disorders,
b) pregnancy
c) myasthenia and myasthenic syndrome - based on neurological examination
d) symptoms of generalized infection,
e) the presence of inflammation
f) permanent contractures in soft tissues and joints,
g) paralysis of the lower limb,
h) pusher syndrome
i) cognitive disorders - MMSE (Mini-Mental State Examination <18),
j) co-morbidities that disturb the gait pattern (eg osteoarthritis).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
3/02/2020
Actual
Date of last data collection
Anticipated
22/02/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21163 0
Poland
State/province [1] 21163 0
Malopolska

Funding & Sponsors
Funding source category [1] 301548 0
University
Name [1] 301548 0
The University of Physical Education
Country [1] 301548 0
Poland
Primary sponsor type
University
Name
The University of Physical Education
Address
31-571 Cracow Al. Jana Pawla II 78
Country
Poland
Secondary sponsor category [1] 301246 0
None
Name [1] 301246 0
Address [1] 301246 0
Country [1] 301246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302282 0
Ethics Committee at the regional medical chamber Cracow
Ethics committee address [1] 302282 0
Ethics committee country [1] 302282 0
Poland
Date submitted for ethics approval [1] 302282 0
Approval date [1] 302282 0
26/03/2018
Ethics approval number [1] 302282 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89682 0
Prof Elzbieta Mirek
Address 89682 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 89682 0
Poland
Phone 89682 0
+48695327424
Fax 89682 0
Email 89682 0
mirek.ela@wp.pl
Contact person for public queries
Name 89683 0
Magdalena Filip
Address 89683 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 89683 0
Poland
Phone 89683 0
+48881304466
Fax 89683 0
Email 89683 0
magdalena.filip@awf.krakow.pl
Contact person for scientific queries
Name 89684 0
Magdalena Filip
Address 89684 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 89684 0
Poland
Phone 89684 0
+48881304466
Fax 89684 0
Email 89684 0
magdalena.filip@awf.krakow.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Beacuse of General Data Protection Regulation (GDPR) we can not make IPD for this trial available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.