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

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Chang Gung University

  collaborator OTHER

• Ministry of Science and Technology, Taiwan

  collaborator OTHER_GOV

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Jen-Wen Hung · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2019-05-07

Completion

2019-05-07

Countries

• Taiwan

Study Locations