Botulinum Toxin, Cerebrovascular Disorders, Spasticity, Muscle
Conditions
Brief summary
The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).
Interventions
DRUGBotulinum toxin type A
Toxin of Clostridium Botulinum
DRUG%0,9 NaCl
%0,9 NaCl
Sponsors
Sisli Hamidiye Etfal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* hemiplegia due to a cerebrovascular accident at least 1 month ago * cognitively competent * have spasticity of 1 and above according to the Modified Ashworth Scale * receive at least 3 cubes in the Box Block Test
Exclusion criteria
* Patients with upper extremity brachial plexus lesions, * shoulder subluxation, * arthritis and joint contracture, * neglect syndrome, * cerebellar and brain stem lesions * those who did not accept the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Fugl-Meyer assessment scale | 2 weeks after treatment | The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity. |
| Pain - Visual Analog Scale | 2 weeks after treatment | The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation. |
| Range of Motion | 2 weeks after treatment | Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension. |
| Modified Ashworth Scale | 2 weeks after treatment | The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain - Visual Analog Scale | 3 months after treatment | The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation. |
| Range of Motion | 3 months after treatment | Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension. |
| Modified Ashworth Scale | 3 months after treatment | The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position. |
| The Fugl-Meyer assessment scale | 3 months after treatment | The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity. |
Outcome results
None listed