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

NCT03321097 | Completed Results

• 1 other identifier: NMRPG8G0211
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A (BoNT-A) injection between condensed and distributed robot-assisted training (RT) programs in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. According to the result of the investigator's ongoing study, the investigators found BoNT-A injection combined with robot-assisted training is recommended to enhance functional recovery for patients with spastic hemiplegic stroke. However, the optimal program as considering the RT frequency is unknown. The aims of this study are to determine and compare the immediate and longer-term effects between condensed and distributed programs of RT following BoNT-A injection in subjects with spastic hemiplegic stroke . Participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to either condensed or distributed RT groups post BoNT-A injection. Each training session included 40 minutes RT, followed by 40-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks, the distributed group 2 sessions per week, for 12 weeks. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale. Activity and participation measures include Wolf Motor Function Test, Motor Activity Log, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 6-week follow-up. The investigators will also use the movement time of robot without powered assistance and surface EMG to determine the motor learning processes of patients receiving the two practice frequencies of RT. This comparative efficacy study will be the first to examine and compare the motor learning processes and immediate and long-term effects between condensed and distributed RT post BoNT injection. The results may provide clinicians with the appropriate methods to scheduling RT following BoNT-A injection to improve upper limb functions for patients with hemiplegic spasticity stroke.

Conditions

Stroke; Hemiplegia, Spastic

Keywords

stroke rehabilitation; spasticity; Botulinum toxin type A injection; robot-assisted therapy; massed therapy; distributed therapy

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment (FMA)

  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.

  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

• Wolf Motor Function Test (WMFT)-Time

  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

  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

• Modified Ashworth Scale (Masiero et al.)

  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.

  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

• Wolf Motor Function Test (WMFT)-Function

  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

  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

Secondary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  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

• Goal Attainment Scale (GAS)

  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

Study Arms (2)

condensed RT group

EXPERIMENTAL

Training session included 45 minutes RT, followed by 30-minute functional training. The condensed group will receive 4 sessions per week, for 6 weeks.

Device: condensed RT group

distributed RT Group

EXPERIMENTAL

Training session included 45 minutes RT, followed by 30-minute functional training. The distributed group 2 sessions per week, for 12 weeks.

Device: distributed RT group

Interventions

condensed RT group DEVICE

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.

Also known as: botulinum toxin injection, InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA)

condensed RT group

distributed RT group DEVICE

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.

Also known as: botulinum toxin injection, InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA)

distributed RT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
• upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon \& Smith, 1987)
• initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, \& Feussner, 1992; Fugl Meyer, Jaasko, \& Leyman, 1975; Park, Wolf, Blanton, Winstein, \& Nichols-Larsen, 2008)
• no serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) (Teng \& Chui, 1987)
• age ≥ 18 years
• willing to provide written informed consent

You may not qualify if:

• pregnant
• with bilateral hemispheric or cerebellar lesions
• sever aphasia
• significant visual field deficits or hemineglect
• contraindication for BoNT-A injection
• treatment with BoNT-A within 4 months before recruitment
• any fixed joint contracture of the affected upper limb
• a history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Chang Gung University: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Kaohsiung City, 833, Taiwan

Location

Related Publications (1)

• Hung JW, Chen YW, Chen YJ, Pong YP, Wu WC, Chang KC, Wu CY. The Effects of Distributed vs. Condensed Schedule for Robot-Assisted Training with Botulinum Toxin A Injection for Spastic Upper Limbs in Chronic Post-Stroke Subjects. Toxins (Basel). 2021 Aug 1;13(8):539. doi: 10.3390/toxins13080539.

  PMID: 34437410 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Results Point of Contact

• Title: Jen-Wen Hung, MD
• Organization: Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

hung0702@cgmh.org.tw

+886975056689

Study Officials

• Jen-Wen Hung

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 25, 2017
• Study Start: October 1, 2017
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2018-08

Locations

TW (1)