NCT05887479

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

April 9, 2023

Last Update Submit

November 20, 2023

Conditions

Cerebrovascular DisordersSpasticity, MuscleBotulinum Toxin

Outcome Measures

Primary Outcomes (4)

  • Pain - Visual Analog Scale

    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.

    2 weeks after treatment

  • Range of Motion

    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.

    2 weeks after treatment

  • Modified Ashworth Scale

    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.

    2 weeks after treatment

  • The Fugl-Meyer assessment scale

    The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.

    2 weeks after treatment

Secondary Outcomes (4)

  • Pain - Visual Analog Scale

    3 months after treatment

  • Range of Motion

    3 months after treatment

  • Modified Ashworth Scale

    3 months after treatment

  • The Fugl-Meyer assessment scale

    3 months after treatment

Study Arms (2)

Study Group

ACTIVE COMPARATOR

This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.

Drug: Botulinum toxin type A

Control Group

PLACEBO COMPARATOR

This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.

Drug: %0,9 NaCl

Interventions

Botulinum toxin type ADRUG

Toxin of Clostridium Botulinum

Study Group
%0,9 NaClDRUG

%0,9 NaCl

Control Group

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebrovascular DisordersMuscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 9, 2023

First Posted

June 2, 2023

Study Start

May 25, 2023

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11