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Trial · NCT05627921

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryModified Tardieu ScaleT0:Patients will be evaluated before botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
PrimaryModified Tardieu ScaleT1:Patients will be evaluated 1 week after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
PrimaryModified Tardieu ScaleT2:Patients will be evaluated 1 month after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
PrimaryModified Tardieu ScaleT3:Patients will be evaluated 3 months after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
PrimaryModified Tardieu ScaleT4:Patients will be evaluated 6 months after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
SecondaryModified Ashworth ScaleT0:Patients will be evaluated before botulinum toxin injection.
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
SecondaryModified Ashworth ScaleT1:Patients will be evaluated 1 week after botulinum toxin injection.
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
SecondaryModified Ashworth ScaleT2:Patients will be evaluated 1 month after botulinum toxin injection.
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
SecondaryModified Ashworth ScaleT3:Patients will be evaluated 3 months after botulinum toxin injection.
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
SecondaryModified Ashworth ScaleT4:Patients will be evaluated 6 months after botulinum toxin injection.
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
SecondaryRange of MotionT0:Patients will be evaluated before botulinum toxin injection.The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
SecondaryRange of MotionT1:Patients will be evaluated 1 week after botulinum toxin injection.The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
SecondaryRange of MotionT2:Patients will be evaluated 1 month after botulinum toxin injection.The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
SecondaryRange of MotionT3:Patients will be evaluated 3 months after botulinum toxin injection.The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
SecondaryRange of MotionT4:Patients will be evaluated 6 months after botulinum toxin injection.The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
SecondaryBIDA( Bodily Functioning Assessment Tool)T0:Patients will be evaluated before botulinum toxin injection.
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
SecondaryBIDA( Bodily Functioning Assessment Tool)T1:Patients will be evaluated 1 month after botulinum toxin injection.
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
SecondaryBIDA( Bodily Functioning Assessment Tool)T2:Patients will be evaluated 3 months after botulinum toxin injection.
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
SecondaryBIDA( Bodily Functioning Assessment Tool)T3:Patients will be evaluated 6 months after botulinum toxin injection.
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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