ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

spasticity

Condition category

Condition code

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Stability, assessed using stabilometric platform

Timepoint [1]