Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000262303
Ethics application status
Approved
Date submitted
30/12/2016
Date registered
20/02/2017
Date last updated
20/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the effects of upper limb rehabilitation program in patients after stroke injecting with botulinum toxin
Scientific title
Analysis of the effects of upper limb rehabilitation program in patients after stroke injecting botulinum toxin based on the clinical tests and stabilometric platform
Secondary ID [1] 290818 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 301486 0
spasticity 301688 0
Condition category
Condition code
Stroke 301190 301190 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 301193 301193 0 0
Physiotherapy
Stroke 301395 301395 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 will consist of the following interactions;
1. Injection preparation of botulinum toxin type A
2. Movement Therapy
Patients will be injected a preparation of botulinum toxin type A. 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 dose of botulinum toxin will be divided between the following structure of the muscle: flexor digitorum profundus (15 - 50 units), flexor digitorum superficialis (15 - 50 units), flexor carpi radialis (15 - 60 units), flexor carpi ulnaris (10 -50 units) flexor pollicis longus (20 units), biceps brachi (50 - 100 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 6 administrations of botox, occurring every 12 weeks. 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 90 minutes) at the study site. Study participants will be evaluated clinically at the time they qualify for each of the six 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 90 minutes.
It will start with 30 min long term elongation of upper limb with use of splints. Then will be 10 min introductory part including warm-up mobilization of joint structures, nerve, muscle and fascial. After the introductory part followed will be 40 minutes of the main part of which included will be active: active exercises of healthy upper limb during supporting on hemi upper limb, active exercises of hemi upper limb in closed kinematic inhibition of associates reactions, exercise of daily activities (ie .: grasp a bottle of water, a cup, a towel, dressing up). Therapy will be completed 10 minutes of relaxing exercises. It will be individual sessions with physiotherapist.
Intervention code [1] 296738 0
Rehabilitation
Intervention code [2] 296900 0
Treatment: Other
Intervention code [3] 297176 0
Treatment: Drugs
Comparator / control treatment
Patients will be injected a preparation of botulinum toxin type A. In controlled clinical trials, patients are administered a dose of the product in the dimension of 100 units. They will be divided between the occupied muscle groups and served during one procedure under the control of ultrasound. The dose of botulinum toxin will be divided between the following structure of the muscle: flexor digitorum profundus (15 - 50 units), flexor digitorum superficialis (15 - 50 units), flexor carpi radialis (15 - 60 units), flexor carpi ulnaris (10 -50 units) flexor pollicis longus (20 units), biceps brachi (50 - 100 units). Injections will always be made by the specialist neurologist
Control group
Active

Outcomes
Primary outcome [1] 300613 0
Stability, assessed using stabilometric platform
Timepoint [1] 300613 0
The outcome assessed at every of Botox injection and at the every last day of 3 weeks rehabilitation
Primary outcome [2] 300614 0
Spasticity symptom severity, assessed using Medical research council scale
Timepoint [2] 300614 0
The outcome assessed at every of Botox injection and at the every last day of 3 weeks rehabilitation
Primary outcome [3] 300615 0
Spasticity symptom severity, assessed using Modified Ashworth Scale
Timepoint [3] 300615 0
The outcome assessed at every of Botox injection and at the every last day of 3 weeks rehabilitation
Secondary outcome [1] 330412 0
Physical function assessed using th timed up and go test
Timepoint [1] 330412 0
The outcome assessed at every of Botox injection and at the every last day of 3 weeks rehabilitation
Secondary outcome [2] 330413 0
Physical function assessed using The Wolf Motor Function Test
Timepoint [2] 330413 0
The outcome assessed at every of Botox injection and at the every last day of 3 weeks rehabilitation

Eligibility
Key inclusion criteria
documented hospitalization due to stroke
occurring post-stroke spasticity of the upper limb (MAS greater than 2 or equal to 2) at least in the one group of muscle
set deadline for rehabilitation no later than three weeks after the Botox injection
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe swallowing disorders and respiratory disorders,
pregnant or breast-feeding,
myasthenic syndrome,
taking medicines that inhibit neuromuscular transmission (eg. aminoglycosides)
general symptoms of infection,
presence of inflammation in the intended site of injection,does not apply to patients who take acenocoumarol or warfarin and on the day of administration, the INR exceeds 2.5,
dementia (MMSE test < 18 pts) - does not apply to patients with aphasia, alexia or agraphia who take acenocoumarol or warfarin and on the day of administration, the INR exceeds 2.5,
settled contraction of the upper limb or muscle atrophy in the hemi upper limb,
hypersensitivity to neurotoxin complex or any of the ingredients of botulinum toxin type A BOTOX A who experienced serious side effects after injection of the drug,
baclofen pump,
paralysis of the hemi upper limb

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
1/05/2017
Actual
Date of last data collection
Anticipated
1/02/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 8534 0
Poland
State/province [1] 8534 0
Malopolska

Funding & Sponsors
Funding source category [1] 295244 0
University
Name [1] 295244 0
The University of Physical Education
Country [1] 295244 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] 294072 0
None
Name [1] 294072 0
none
Address [1] 294072 0
none
Country [1] 294072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296583 0
Ethics Committee at the regional medical chamber Cracow
Ethics committee address [1] 296583 0
ul. Krupnicza 11 a
31-123 Cracow
Ethics committee country [1] 296583 0
Poland
Date submitted for ethics approval [1] 296583 0
14/06/2016
Approval date [1] 296583 0
20/06/2016
Ethics approval number [1] 296583 0
99/KBL/OIL/2016

Summary
Brief summary
Stroke is one of the main causes of disability and mortality in the world by acting not only a significant medical problem but also, due to permanent disability of patients and the costs of their hospitalization, long-term care and rehabilitation, significant economic and social problems. The aim of the study is to evaluate the effect of physiotherapy of the upper limb in patients with stroke injecting botulinum toxin based on clinical trials and stabilometric platform. Patients will be recruited from the general population through local medical centers. They will be randomly divided into a control group and intervention group. Patients in the intervention group will be submitted to 6 cycles of intramuscular injections of botulinum toxin. Subsequent injections of Botox will be performed every 12 weeks. Each time, after 3 weeks of administration, patients will take part in the ongoing three weeks of individual therapeutic exercise program. Patients in the control group will be injected with botulin toxin only once and after 12 weeks they will be evaluated again..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71370 0
Dr Elzbieta Mirek
Address 71370 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 71370 0
Poland
Phone 71370 0
+48695327424
Fax 71370 0
Email 71370 0
[email protected]
Contact person for public queries
Name 71371 0
Dr Magdalena Filip
Address 71371 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 71371 0
Poland
Phone 71371 0
+48881304466
Fax 71371 0
Email 71371 0
[email protected]
Contact person for scientific queries
Name 71372 0
Dr Magdalena Fiip
Address 71372 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education
Country 71372 0
Poland
Phone 71372 0
+48881304466
Fax 71372 0
Email 71372 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIThe influence of motor ability rehabilitation on temporal-spatial parameters of gait in Huntington's disease patients on the basis of a three-dimensional motion analysis system: An experimental trial2018https://doi.org/10.1016/j.pjnns.2018.02.001
N.B. These documents automatically identified may not have been verified by the study sponsor.