Trial Outcomes & Findings for Compensatory Kinematic Movements in Various Directions After Stroke (NCT NCT05683158)

NCT ID: NCT05683158

Last Updated: 2025-02-24

Results Overview

Trunk dislocation (reaching phase in millimetre; mm) in reaching task. The measurements are detected in 3 directions (Forward\_90, Lateral\_135, Medial\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

• Recruitment status: COMPLETED
• Target enrollment: 96 participants
• Primary outcome timeframe: 1 time (Baseline)
• Results posted on: 2025-02-24

Participant Flow

Participants were recruited based on physician's confirmation of chronic hemiplegia with ≥ 6 months onset and the healthy group consisted of individuals without any history of neurological or orthopedic diseases. The participants was enrolled from August, 2022 to June, 2023 at the gym for the disabled of Ulsan city and Ulsan national institute of science and technology

All of the subjects of 96 enrolled participants were inclusion criteria

Participant milestones

Measure	Chronic Stroke The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Overall Study STARTED	35	61
Overall Study COMPLETED	35	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Total n=96 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=61 Participants	0 Participants n=96 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=35 Participants	18 Participants n=61 Participants	30 Participants n=96 Participants
Age, Categorical >=65 years	23 Participants n=35 Participants	43 Participants n=61 Participants	66 Participants n=96 Participants
Age, Continuous	68.80 years STANDARD_DEVIATION 13.81 • n=35 Participants	68.61 years STANDARD_DEVIATION 7.23 • n=61 Participants	68.67 years STANDARD_DEVIATION 10.09 • n=96 Participants
Sex: Female, Male Female	17 Participants n=35 Participants	32 Participants n=61 Participants	49 Participants n=96 Participants
Sex: Female, Male Male	18 Participants n=35 Participants	29 Participants n=61 Participants	47 Participants n=96 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	35 participants n=35 Participants	61 participants n=61 Participants	96 participants n=96 Participants
Fugl-Meyer Assessment (FMA)	51 units on a scale n=35 Participants	66 units on a scale n=61 Participants	66 units on a scale n=96 Participants

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Trunk dislocation (reaching phase in millimetre; mm) in reaching task. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Trunk dislocation (mm)_Forward	272.44 millimeter Standard Deviation 88.63	221.24 millimeter Standard Deviation 71.37
Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Trunk dislocation (mm)_Lateral	288.14 millimeter Standard Deviation 90.99	253.50 millimeter Standard Deviation 74.54
Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Trunk dislocation (mm)_Medial	274.83 millimeter Standard Deviation 88.31	230.76 millimeter Standard Deviation 80.51

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Elbow extension and shoulder flexion angle (degree) in reaching task. The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow extension_Forward	132.27 Degree Standard Deviation 20.53	131.97 Degree Standard Deviation 9.26
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow extension_Lateral	133.70 Degree Standard Deviation 19.44	135.20 Degree Standard Deviation 13.20
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow extension_Medial	127.04 Degree Standard Deviation 24.93	127.46 Degree Standard Deviation 12.31
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Shoulder flexion_Forward	131.49 Degree Standard Deviation 19.39	123.29 Degree Standard Deviation 18.12
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Shoulder flexion_Lateral	130.95 Degree Standard Deviation 21.43	128.64 Degree Standard Deviation 13.39
Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Shoulder flexion_Medial	135.00 Degree Standard Deviation 18.55	123.67 Degree Standard Deviation 13.80

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Movement units are quantified by counting velocity peaks during the reaching task. A movement unit is defined as a velocity profile segment between a local minimum and the following maximum velocity that exceeds 20 mm/s, with a minimum time interval of 150 ms between subsequent peaks. This measure represents the smoothness of movement, where fewer movement units indicate smoother motion The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Movement unit_Forward	4.47 number of peaks Standard Deviation 2.17	3.18 number of peaks Standard Deviation 0.80
Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Movement unit_Lateral	5.02 number of peaks Standard Deviation 2.60	2.63 number of peaks Standard Deviation 0.67
Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Movement unit_Medial	4.11 number of peaks Standard Deviation 1.94	2.66 number of peaks Standard Deviation 0.76

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

The period from hand tangential velocity movement onset to offset was the total time (entire time of reach and return phase [second]). The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset.

The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Total time_Forward	3.42 second Standard Deviation 1.13	2.09 second Standard Deviation 0.44
Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Total time_Lateral	3.49 second Standard Deviation 1.21	2.07 second Standard Deviation 0.40
Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Total time_Medial	3.26 second Standard Deviation 1.02	1.98 second Standard Deviation 0.37

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Tangential velocity was computed for the hand marker's velocity. Peak elbow angular velocity (rad/s) during elbow extension were measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular velocity_Forward	45.66 rad/s Standard Deviation 31.21	75.40 rad/s Standard Deviation 39.87
Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular velocity_Lateral	44.04 rad/s Standard Deviation 29.60	76.47 rad/s Standard Deviation 43.44
Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular velocity_Medial	53.74 rad/s Standard Deviation 37.60	79.15 rad/s Standard Deviation 38.79

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Acceleration (rad/s2) during elbow extension was measured The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular acceleration_Forward	344.75 rad/s2 Standard Deviation 261.56	628.85 rad/s2 Standard Deviation 270.49
Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular acceleration_Lateral	321.28 rad/s2 Standard Deviation 199.17	542.96 rad/s2 Standard Deviation 281.04
Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients Elbow angular acceleration_Medial	396.78 rad/s2 Standard Deviation 320.56	722.87 rad/s2 Standard Deviation 280.19

PRIMARY outcome

Timeframe: 1 time (Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Tangential velocity was computed for the hand marker's velocity. The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. Peak hand velocity (mm/s) was analyzed.

The measurements are detected in 3 directions (Forward_90, Lateral_135, Medial_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Difference of the Components Temporal Measurements Between Healthy and Stroke Hand velocity_Forward	944.52 mm/s Standard Deviation 610.70	805.28 mm/s Standard Deviation 324.31
Difference of the Components Temporal Measurements Between Healthy and Stroke Hand velocity_Lateral	1003.22 mm/s Standard Deviation 634.69	822.19 mm/s Standard Deviation 270.58
Difference of the Components Temporal Measurements Between Healthy and Stroke Hand velocity_Medial	1015.06 mm/s Standard Deviation 675.14	1188.89 mm/s Standard Deviation 497.50

SECONDARY outcome

Timeframe: Baseline

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Related Fugl-Meyer Assessment score(dependent) to predictors(independent) in three directions.

In sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score. Cutoff scores defined 0~20: severe, 21 ~ 50: moderate, 51~66: mild

1) Reflex activity_max 4 score, 2) Volitional movement within synergies_ max 18, 3) Volitional movement mixing synergies_ max 6, 4) Volitional movement with little or no synergy_ max 6, 5) Normal reflex activity_max 2, 6) Wrist movement_ max 10, 7) Hand movement with grasp_ max 14, 8) coordination/speed_max 6.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy	51 score on a scale Interval 32.0 to 64.0	66 score on a scale Interval 66.0 to 66.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Scoring for Biceps

• MAS 0: No increase in tone
• MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.
• MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )
• MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
• MAS 3: considerable increase in tone, passive movement difficult
• MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls	2 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Shoulder and elbow joint range of motion

• Shoulder flexion, adduction, abduction, external rotation, internal rotation
• Elbow flexion, extension

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Range of motion_Health Status Chronic Stroke Shoulder flexion	161.46 degree Standard Deviation 22.16	179.02 degree Standard Deviation 7.68
Range of motion_Health Status Chronic Stroke Shoulder abduction	149.57 degree Standard Deviation 34.11	179.26 degree Standard Deviation 5.76
Range of motion_Health Status Chronic Stroke Shoulder adduction	44.77 degree Standard Deviation 8.82	50.00 degree Standard Deviation 0
Range of motion_Health Status Chronic Stroke Shoulder external rotation	71.86 degree Standard Deviation 19.18	89.51 degree Standard Deviation 2.36
Range of motion_Health Status Chronic Stroke Shoulder internal rotation	76.94 degree Standard Deviation 19.79	87.70 degree Standard Deviation 8.09
Range of motion_Health Status Chronic Stroke Elbow flexion	139.63 degree Standard Deviation 7.29	144.18 degree Standard Deviation 3.05
Range of motion_Health Status Chronic Stroke Elbow extension	1.94 degree Standard Deviation 5.26	0 degree Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 time(Baseline)

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

The Trunk Impairment Scale (TIS) for stroke has a total score of 23 points, with higher scores indicating better trunk control ability. TIS components:

Static sitting balance - 7 points Dynamic sitting balance - 10 points Coordination - 6 points 23 points = Optimal trunk control ability (normal performance of all items) 0 points = Minimal trunk control ability (unable to perform) Static sitting balance Dynamic sitting balance Co-ordination

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Trunk Impairment Scale(TIS)_Health Status Chronic Stroke	14 score on a scale Interval 11.0 to 20.0	23 score on a scale Interval 23.0 to 23.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

The Postural Assessment Scale for Stroke (PASS) evaluates postural control in stroke patients, with scores ranging from 0-36 points, where higher scores indicate better functional recovery.

1) Sitting without support 2,3) Standing with(without) support 4,5) Standing on (non)paretic leg 6) Supine to affected side lateral 7) Supine to non-affected side lateral 8) Supine to sitting up on the edge of the table 9) Sitting on the edge of the table to supine 10) Sitting to standing up 11) Standing up to sitting down 12) Standing, picking up a pencil from the floor

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Postural Assessment Scale for Stroke(PASS)_Health Status Chronic Stroke	33 score on a scale Interval 32.0 to 34.0	36 score on a scale Interval 36.0 to 36.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Upper extremity The total score means that severe <20, 20=<moderate<60, 60=<mild. Higher scores on the Fugl-Meyer Assessment indicate better upper limb motor control with reduced synergistic patterns, while lower scores indicate stronger synergistic patterns due to spasticity

1) Reflex activity_max 4 score, 2) Volitional movement within synergies_ max 18, 3) Volitional movement mixing synergies_ max 6, 4) Volitional movement with little or no synergy_ max 6, 5) Normal reflex activity_max 2, 6) Wrist movement_ max 10, 7) Hand movement with grasp_ max 14, 8) coordination/speed_max 6.

• Shoulder, Elbow and Forearm

1. Reflex activity

2. Volitional movement within synergies

3. Volitional movement mixing synergies

4. Volitional movement with little or no synergy

5. Normal reflex activity

• Wrist
• Hand
• Coordination/Speed
• Total score is 66 points

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy

Scoring for Triceps

• MAS 0: No increase in tone
• MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.
• MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )
• MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
• MAS 3: considerable increase in tone, passive movement difficult
• MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.

Outcome measures

Measure	Chronic Stroke n=35 Participants The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)	Healthy n=61 Participants Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees)
Modified Ashworth Scale_Stiffness of Chronic Stroke	1 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 0.0

Adverse Events

Chronic Stroke

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy

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

PI. Jose Casaña Granell

Department of Physiotherapy, University of Valencia

Phone: +34 656-437-371

Email: jose.casana@uv.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place