Trial Outcomes & Findings for Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions (NCT NCT03563209)

Last Updated: 2019-05-22

Results Overview

According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

1 day (Only one measurement was performed in time (cross-sectional))

Results posted on

2019-05-22

Participant Flow

This study enrolled patients with post-stroke elbow flexor spasticity from a single medical center in Turkey. The last patients completed in July 2018

Participant milestones

Participant milestones
Measure	Post-stroke Elbow Flexor Spasticity Participants with post-stroke elbow flexor spasticity
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Post-stroke Elbow Flexor Spasticity n=60 Participants Participants with post-stroke elbow flexor spasticity
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	57.82 years STANDARD_DEVIATION 12.66 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Turkey	60 participants n=5 Participants
Type of stroke Ischemic	45 Participants n=5 Participants
Type of stroke Hemoragic	15 Participants n=5 Participants
Side of plegia Right	26 Participants n=5 Participants
Side of plegia Left	34 Participants n=5 Participants
Disease duration	38 months n=5 Participants
Brunnstrom stage of motor recovery of upper extremity	3 units on a scale n=5 Participants
Brunnstrom stage of motor recovery of hand	3 units on a scale n=5 Participants
Brunnstrom stage of motor recovery of lower extremity	3 units on a scale n=5 Participants
Severity of spasticity according to the Modified Ashworth Scale in forearm pronation	3 units on a scale n=5 Participants
Severity of spasticity according to the Modified Ashworth Scale in the neutral position of forearm	3 units on a scale n=5 Participants
Severity of spasticity according to the Modified Ashworth Scale in forearm supination	3 units on a scale n=5 Participants
Spontaneous elbow angle	118.17 degree STANDARD_DEVIATION 23.09 • n=5 Participants
Slow controlled motion (passive range of motion) of elbow joint in pronation	180 degree n=5 Participants
Slow controlled motion (passive range of motion) of elbow joint in the neutral position of forearm	180 degree n=5 Participants
Slow controlled motion (passive range of motion) of elbow joint in supination	180 degree n=5 Participants
Angle of muscle reaction in pronation	110 degree n=5 Participants
Angle of muscle reaction in the neutral position	115 degree n=5 Participants
Angle of muscle reaction in supination	120 degree n=5 Participants
Quality of muscle reaction in pronation	2 units on a scale n=5 Participants
Quality of muscle reaction in the neutral position of forearm	2 units on a scale n=5 Participants
Quality of muscle reaction in supination	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 1 day (Only one measurement was performed in time (cross-sectional))

Outcome measures

Outcome measures
Measure	Spasticity Angle in Pronation n=60 Participants First group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the pronation position of forearm	Spasticity Angle in Neutral Position n=60 Participants Second group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the neutral position of forearm	Spasticity Angle in Supination n=60 Participants Third group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the supination position of forearm
Dynamic Component of Spasticity (Spasticity Angle)	70 degree Interval 50.0 to 80.0	60 degree Interval 50.0 to 75.0	57.5 degree Interval 30.0 to 70.0

Adverse Events

Post-stroke Elbow Flexor Spasticity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

ilker şengül

İzmir Katip Çelebi University, Faculty of Medicine

Phone: 05337333698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place