Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection

NCT03807557 | Completed

• 1 other identifier: CMRPG8H1261
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection. Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day). Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants. Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) \* 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.

Conditions

Stroke; Hemiplegia, Spastic

Keywords

Stroke rehabilitation; Botulinum toxin type A injection; robot-assisted therapy; Constraint-induced movement therapy; spasticity

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, and the maximum score is 66. Satisfactory psychometric properties of the FMA have been demonstrated(Platz et al., 2005)

  Change from baseline at 1.5 months

• Modified Ashworth Scale

  Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon \& Smith, 1987).It uses a 6-point 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).

  Change from baseline at 1.5 months

• Actigraph

  The amount of the impaired arm movement will be assessed by the activity monitors (i.e. accelerometers)(Schasfort, Busmann, Martens, \& Stam, 2006; Uswatte, Giuliani, et al., 2006; Uswatte et al., 2000). Accelerometers, objectively recording the amount of activity in free-living conditions and estimating energy expenditure, have been applied to measure the amount of affected arm use over time. In addition, accelerometers were also used to provide a measure of sleep latency and efficiency in this project. The participants were required to comply with wearing the accelerometer on each arm for 3 consecutive days. The accelerometers used in this project will be wireless plastic units about the size and weight of a large wrist watch. The participants will wear them proximal to the wrist on terrycloth bands. The compliance of wearing accelerometers was approximately 76% of waking time (Schasfort et al., 2006).

  Change from baseline at 1.5 months

• Wolf Motor Function Test (WMFT)

  The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Uswatte, Taub, Stuss, Winocur, \& Robertson, 1999). The WMFT includes 17 tasks (15 function-based and 2 strength-based). Performances were timed and rated by using a 6-point ordinal scale. The WMFT has good interrater reliability and criterion validity in patients with UE hemiparesis (D. M. Morris, Uswatte, Crago, Cook, \& Taub, 2001) .

  Change from baseline at 1.5 months

Secondary Outcomes (3)

• Motor Activity Log (MAL)

  Change from baseline at 1.5 months

• Nottingham Extended Activities of Daily Living Scale (NEADL)

  Change from baseline at 1.5 months

• Goal attainment scale (GAS)

  Change from baseline at 1.5 months

Study Arms (2)

Robotic mCIMT group

EXPERIMENTAL

1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day

Other: Robotic Constraint-induced movement therapy

Control group

ACTIVE COMPARATOR

conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day

Other: conventional UE rehabilitation training

Interventions

Robotic Constraint-induced movement therapy OTHER

i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique. ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks. iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic.

Robotic mCIMT group

conventional UE rehabilitation training OTHER

focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months; (2) 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); (3) 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); (4) no serious cognitive impairment (i.e., Mini Mental State Exam score \> 20) (Teng \& Chui, 1987); (5) age ≥ 20 years ; and (6) willing to provide written informed consent.

You may not qualify if:

• \. pregnant 2. with bilateral hemispheric or cerebellar lesions 3. sever aphasia 4. significant visual field deficits or hemineglect 5. contraindication for BoNT-A injection 6. treatment with BoNT-A within 4 months before recruitment 7. any fixed joint contracture of the affected upper limb 8. 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

Study Sites (1)

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

Kaohsiung City, Taiwan

Location

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

Study Officials

• Jen-Wen Hung

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

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: January 15, 2019
• First Posted: January 17, 2019
• Study Start: January 30, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 29, 2021

Record last verified: 2020-03

Locations

TW (1)