Trial Outcomes & Findings for Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection (NCT NCT04826900)
NCT ID: NCT04826900
Last Updated: 2023-09-15
Results Overview
Fugl-Meyer Assessment for Upper Extremity (FMA-UE): The FMA-UE was used to assess the patient's reflexes, movements, and coordination of upper limbs. It consists of 33 items scored on a 3-point ordinal scale (0, cannot perform; 1, performs partially; 2, performs fully). (Fugl-Meyer, Jääskö, Leyman, Olsson, \& Steglind, 1975) . The total score ranges from 0 to 66, and a higher score indicates better motor function. Satisfactory psychometric properties of the FMA have been demonstrated. (Thomas Platz et al., 2005).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Change from baseline at 5 months
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
Robotic Group
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Robotic Group
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
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|---|---|---|
|
Overall Study
Family factor
|
1
|
1
|
Baseline Characteristics
Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection
Baseline characteristics by cohort
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
47.07 years
STANDARD_DEVIATION 10.36 • n=93 Participants
|
48.60 years
STANDARD_DEVIATION 9.65 • n=4 Participants
|
47.86 years
STANDARD_DEVIATION 9.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
14 participants
n=93 Participants
|
15 participants
n=4 Participants
|
29 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 5 monthsFugl-Meyer Assessment for Upper Extremity (FMA-UE): The FMA-UE was used to assess the patient's reflexes, movements, and coordination of upper limbs. It consists of 33 items scored on a 3-point ordinal scale (0, cannot perform; 1, performs partially; 2, performs fully). (Fugl-Meyer, Jääskö, Leyman, Olsson, \& Steglind, 1975) . The total score ranges from 0 to 66, and a higher score indicates better motor function. Satisfactory psychometric properties of the FMA have been demonstrated. (Thomas Platz et al., 2005).
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
3 score on a scale
Interval -0.25 to 8.25
|
6 score on a scale
Interval 5.0 to 9.0
|
PRIMARY outcome
Timeframe: Change from baseline at 5 monthsThe MRC scale will be used to examine the muscle strength of the affected arm (Medical Research Council, 1976). The MRC scale is a reliable measurement which ranges from 0 (no contraction) to 5 (normal power). The muscle strength will be measured at the shoulder flexor/abductor, elbow flexors/extensors, wrist flexors/extensors, and finger flexors/extensors by using the MRC in this project. Total scale combines all range and computes average scores. Flexor scale combines elbow flexors, wrist flexors, fingers flexors and computes average scores. Proximal scale combines shoulder flexor/abductor, elbow flexors/extensors, and computes average scores. Distal scale combines wrist flexors/extensors, and finger flexors/extensors. The higher scores mean a better outcome.
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Medical Research Council Scale (MRC)
Total
|
0.30 score on a scale
Interval 0.03 to 0.71
|
0.35 score on a scale
Interval 0.2 to 0.6
|
|
Medical Research Council Scale (MRC)
Flexor
|
0.17 score on a scale
Interval -0.17 to 0.5
|
0.17 score on a scale
Interval 0.0 to 0.5
|
|
Medical Research Council Scale (MRC)
Finger Flexor
|
0.25 score on a scale
Interval 0.0 to 0.5
|
0.50 score on a scale
Interval 0.0 to 1.0
|
|
Medical Research Council Scale (MRC)
Finger Extensor
|
0.25 score on a scale
Interval 0.0 to 0.63
|
0.00 score on a scale
Interval 0.0 to 1.0
|
|
Medical Research Council Scale (MRC)
Proximal
|
0.33 score on a scale
Interval -0.19 to 0.6
|
0.42 score on a scale
Interval 0.25 to 0.5
|
|
Medical Research Council Scale (MRC)
Distal
|
0.40 score on a scale
Interval 0.0 to 0.75
|
0.42 score on a scale
Interval 0.13 to 0.63
|
PRIMARY outcome
Timeframe: Change from baseline at 5 monthsSpasticity of skeletal muscle in upper extremity was evaluated by using the MAS scale. It uses a 8-point scale(0, 1, 1.5, 2, 2.5, 3, 3.5, 4) to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity. We assessed the MAS of shoulder flexor/extensor/abductor/adductor, elbow flexors/extensors, forearm pronator/supinator, wrist flexors/extensors, and finger flexors/extensors in this project. Total scale combines all range and computes average scores. Flexor scale combines elbow extensor, wrist extensor, fingers extensor and computes average scores. Proximal scale combines shoulder flexor/extensor/abductor/adductor, elbow flexors/extensors and computes average scores. Distal scale combines forearm pronator/supinator, wrist flexors/extensors, and finger flexors/extensors. The maximum of MAS scale is 4, and the minimum is 0. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Modified Ashworth Scale (MAS)
Total
|
-0.33 score on a scale
Interval -0.36 to -0.16
|
-0.17 score on a scale
Interval -0.25 to -0.08
|
|
Modified Ashworth Scale (MAS)
Flexor
|
-0.42 score on a scale
Interval -0.67 to 0.0
|
-0.17 score on a scale
Interval -0.33 to 0.0
|
|
Modified Ashworth Scale (MAS)
Finger Flexor
|
-0.25 score on a scale
Interval -0.63 to 0.5
|
0.00 score on a scale
Interval -0.5 to 0.0
|
|
Modified Ashworth Scale (MAS)
Proximal
|
-0.17 score on a scale
Interval -0.29 to -0.06
|
-0.08 score on a scale
Interval -0.25 to -0.08
|
|
Modified Ashworth Scale (MAS)
Distal
|
-0.38 score on a scale
Interval -0.69 to -0.15
|
-0.33 score on a scale
Interval -0.42 to -0.25
|
PRIMARY outcome
Timeframe: Change from baseline at 5 monthsThe BBT, which evaluates manual dexterity of the paretic UE, uses a wooden box that has two equally sized compartments. Cubes were placed in one compartment, and the participants were instructed to move the cubes to the other compartment one by one and as quickly as possible within 60 seconds. The score was determined by calculating the number of cubes carried across the partition. The BBT has high test-retest reliability in participants with stroke(Thomas Platz et al., 2005).
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Box and Block Test (BBT)
|
0 cubes/minute
Interval 0.0 to 1.25
|
0 cubes/minute
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Change from baseline at 5 monthsThe MAL is a semi-structured interview to rate how much \[amount of use scale (AOU)\] they use their affected upper extremity in 30 daily activities using a 6-point scale. Higher scores represent better performance. The MAL has established reliability, validity, and responsiveness in patients with stroke. The MAL will be used to measure daily use of the affected upper limb in daily life in this project.The total score ranges from 0 to 30.
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Motor Activity Log (MAL) - Amount of Use Scale (AOU)
|
0.14 score on a scale
Interval -0.02 to 0.64
|
0.34 score on a scale
Interval 0.05 to 0.96
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PRIMARY outcome
Timeframe: Change from baseline at 5 monthsThe MAL is a semi-structured interview to rate how well \[quality of movement scale (QOM)\] they use their affected upper extremity in 30 daily activities using a 6-point scale. Higher scores represent better performance. The MAL has established reliability, validity, and responsiveness in patients with stroke. The MAL will be used to measure daily use of the affected upper limb in daily life in this project.The total score ranges from 0 to 30.
Outcome measures
| Measure |
Robotic Group
n=14 Participants
Training session included 45 minutes Robotic Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic therapy (RT): A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box.
Functional task training: After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks training will be bases on the needs and ability of patients.
|
Robotic Mirror Group
n=15 Participants
Training session included 45 minutes Robotic Mirror Therapy, followed by 15-minute functional training. The robotic group will receive 3 sessions per week, for 8 weeks.
BoNT-A injections: Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
Robotic mirror therapy (RMT): Wearable robotic hand system and mirror system will be used in this group.The patients in the group will wear the robotic hand to do the mirror therapy.
Functional task training: After either 45 minutes of RMT, all participants receive 15 minutes of training in functional tasks.The functional tasks training will be bases on the needs and ability of patients.
|
|---|---|---|
|
Motor Activity Log (MAL) - Quality of Movement Scale (QOM)
|
0.15 score on a scale
Interval 0.03 to 0.35
|
0.21 score on a scale
Interval 0.13 to 0.53
|
Adverse Events
Robotic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Robotic Mirror Group
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
Jen-Wen Hung, MD
Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Phone: +886975056689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place