Trial Outcomes & Findings for Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection (NCT NCT03321097)

NCT ID: NCT03321097

Last Updated: 2020-06-23

Results Overview

The upper-extremity (UE) subscale of the FMA will be used to assess neuromusculoskeletal and movement related functions. It consists of 33 upper extremity items for the reflexes and movement of shoulder, elbow, forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully)(Fugl Meyer et al., 1975). Higher score indicates better motor function of UE. The maximum score is 66, and the minimum score is 0. Satisfactory psychometric properties of the FMA have been demonstrated(Hsueh \& Hsieh, 2002;Platz et al., 2005). The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported
• Results posted on: 2020-06-23

Participant Flow

Participant milestones

Measure	Condensed RT Group Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection

Baseline characteristics by cohort

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Total n=36 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	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	51.73 years STANDARD_DEVIATION 13.21 • n=93 Participants	53 years STANDARD_DEVIATION 8.27 • n=4 Participants	52.36 years STANDARD_DEVIATION 10.88 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Race/Ethnicity, Customized Asia	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Region of Enrollment Taiwan	18 participants n=93 Participants	18 participants n=4 Participants	36 participants n=27 Participants

PRIMARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

The upper-extremity (UE) subscale of the FMA will be used to assess neuromusculoskeletal and movement related functions. It consists of 33 upper extremity items for the reflexes and movement of shoulder, elbow, forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully)(Fugl Meyer et al., 1975). Higher score indicates better motor function of UE. The maximum score is 66, and the minimum score is 0.

Satisfactory psychometric properties of the FMA have been demonstrated(Hsueh & Hsieh, 2002;Platz et al., 2005).

The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention.

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Fugl-Meyer Assessment (FMA)	3.45 score on a scale Standard Deviation 4.22	1.94 score on a scale Standard Deviation 2.29

PRIMARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks. The WMFT includes 17 tasks (15 function-based and 2 strength-based). In this study only 15 function-based tasks were used. Performances were timed and rated by using a 6-point ordinal scale ranging from 0 to 5 ,There are 2 different scores: the WMFT -Time (time required to complete the tasks) and WMFT -FAS (functional Ability Scale, where a score of 6 points is used to assess the functional capacity of each task: 0 indicating that the patient cannot attempt the task, and 5 where the movement seems normal) The item ratings and time are summed respectively, and the average item rating and time are reported.The minimum value of mean FAS is 0, maximum 5, the higher the better.

The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after in

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Wolf Motor Function Test (WMFT)-Time	-6.31 seconds Standard Deviation 2.29	-7.89 seconds Standard Deviation 3.24

PRIMARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon & Smith, 1987). It uses a 6-level scale 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 (Pandyan et al., 1999). The maximum of MAS scale is 4, and the minimum is 0.

The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), post intervention, 6 weeks after intervention.

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Modified Ashworth Scale (Masiero et al.) Proximal	0.98 score on a scale Standard Deviation 0.33	1.07 score on a scale Standard Deviation 0.48
Modified Ashworth Scale (Masiero et al.) Distal	1.10 score on a scale Standard Deviation 0.55	1.43 score on a scale Standard Deviation 0.50

PRIMARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks. The WMFT includes 17 tasks (15 function-based and 2 strength-based). In this study only 15 function-based tasks were used. Performances were timed and rated by using a 6-point ordinal scale ranging from 0 to 5 ,There are 2 different scores: the WMFT -Time (time required to complete the tasks) and WMFT -FAS (functional Ability Scale, where a score of 6 points is used to assess the functional capacity of each task: 0 indicating that the patient cannot attempt the task, and 5 where the movement seems normal) The item ratings and time are summed respectively, and the average item rating and time are reported.The minimum value of mean FAS is 0, maximum 5, the higher the better.

The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after in

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Wolf Motor Function Test (WMFT)-Function	2.32 score on a scale Standard Deviation 0.48	2.20 score on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

The COPM, a semi-structured interview, will be used to assess a participant's perception of the performance in the areas of self-care, productivity and leisure (Dedding, Cardol, Eyssen, & Beelen, 2004). The COPM can capture information about activities that the participant wants, needs or is expected to perform. The participant will be asked to rate five most important activities on a 10-point scale for performance, ranging from 1 (not at all able) to 10 (able to perform extremely well), and for satisfaction, ranging from 1 (not at all satisfied) to 10 (extremely satisfied)(Dedding et al.,2004). The COPM is a reliable, valid, and responsive outcome measure for practitioners and researchers (Carswell et al., 2004).

The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention.

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Canadian Occupational Performance Measure (COPM) Satisfication	5.94 score on a scale Standard Deviation 2.16	5.45 score on a scale Standard Deviation 2.1
Canadian Occupational Performance Measure (COPM) Performance	5.60 score on a scale Standard Deviation 1.86	5.45 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported

The Goal Attainment Scale (GAS) is a measure of participants' individual goals that could be achieved in the course of intervention. Each goal will be rated on a 5-point scale ranging from -2 to +2 (maximum +2, minimum -2, the higher score indicates a better outcome. ) These attainment levels were combined in a single T-score by applying the formula recommended by Kiresuk & Sherman, which accounts for variable numbers of goals, inter-correlation of goal areas and variable weighting: Total score = 50 +{(10Σ(wi xi ))/(0.7Σwi 2 + 0.3(Σwi )2 )½} where wi =weight assigned to the ith goal and xi = the score of the ith goal. In the first session, the therapist will discuss with the participants and their families to define the goals. In the last session, the therapist use the GAS to qualify interpretation results.

The outcome is measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), post-intervention, 6 weeks after intervention.

Outcome measures

Measure	Condensed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks. condensed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.	Distributed RT Group n=18 Participants Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks. distributed RT group: 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. Training procedures There are total 24 training sessions following one week after injection. Participants in the distributed practice group will receive 2 sessions per week, for 12 weeks. During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice.
Goal Attainment Scale (GAS)	47.11 T score Standard Deviation 7.90	51.83 T score Standard Deviation 6.92

Adverse Events

Condensed RT Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Distributed RT 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: hung0702@cgmh.org.tw

Results disclosure agreements

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