Combining Robotic-Assisted Therapy and Pharmacotherapy in Post-Stroke Rehabilitation

NCT02346630 | Withdrawn Phase 4

• 1 other identifier: 2013-P-002440
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the leading cause of acquired long-term disability in adults in developed countries. Despite aggressive rehabilitation, lasting upper extremity impairment remains in the majority of stroke survivors. It is hypothesized that enhancing neuroplasticity through the combination of drug therapy and physical therapy could enhance outcomes for stroke survivors. The combination of levodopa and intensive physical therapy shows promise in enhancing the functional motor recovery of stroke patients during the sub-acute and chronic period without reported significant side effects. Robotic-aided training is a promising tool that has the potential to deliver high-intensity, task-oriented, reproducible therapy that can decrease the burden on a therapist. Since the evidence behind dopaminergic potentiation of neuroplasticity and stroke recovery is promising, it is the investigators aim to combine dopaminergic drug therapy with highly intensive robotic-assisted therapy to provide superior upper extremity functional recovery over traditional stroke rehabilitation.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Upper Extremity Score of the Fugl-Meyer Assessment (FM-UE) at 1 month

  FM-UE is an ordinal scale with scores ranging from 0 to 66 for upper-limb motor performance. It is composed of 33 items. FM-UE is a measure of upper-extremity motor impairment including coordination and speed.

  month 1

Secondary Outcomes (8)

• Computer Measures on the Armeo Robot

  month 1

• Analysis of Muscle Activation Patterns During Upper Extremity Movements

  month 1

• Transcranial Magnetic Stimulation Assessment (TMS)

  month 1

• Veteran's Rand 36

  month 1

• Hand Dynamometry

  month 1

Study Arms (2)

Levodopa / Carbidopa + Armeo

ACTIVE COMPARATOR

Levodopa / Carbidopa drug 100/25 mg once a day for 3 weeks. Armeo Robotic Assisted Intensive Upper Extremity Therapy every weekday for 3 weeks.

Drug: Levodopa / Carbidopa; Device: Armeo

Placebo + Armeo

PLACEBO COMPARATOR

Placebo capsules daily for 3 weeks. Armeo Robotic Assisted Intensive Upper Extremity Therapy every weekday for 3 weeks.

Drug: Placebo; Device: Armeo

Interventions

Placebo DRUG

Placebo capsules daily for 3 weeks.

Also known as: Negative control

Placebo + Armeo

Levodopa / Carbidopa DRUG

Levodopa / Carbidopa drug 100/25 mg once a day for 3 weeks.

Also known as: Sinemet

Levodopa / Carbidopa + Armeo

Armeo DEVICE

Armeo Robotic Assisted Intensive Upper Extremity Therapy every weekday for 3 weeks.

Levodopa / Carbidopa + Armeo; Placebo + Armeo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, community dwelling, age 18-85.
• First episode of stroke.
• Diagnosis of chronic ischemic stroke at least six months before study enrollment resulting in objective motor upper-extremity impairment as demonstrated during physical/neurological examination.
• Score of 15-55 out of 66 on the arm motor Fugl-Meyer scale.
• The ability to extend ≥ 10 degrees at metacarpophalangeal and interphalangeal joint of all digits.
• Signed written informed consent.

You may not qualify if:

• Intracranial hemorrhages.
• Pregnancy, planning to become pregnant or breast-feeding.
• History of seizures within the previous six months.
• Previous residual motor deficit in the affected side.
• Treatment with Botox injections in the affected arm in the previous 6 months.
• Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools.
• Other major neurologic disorder (Parkinson's disease).
• Major depression defined by the Patient Health Questionnaire, other major psychiatric pathology, dementia, agitation (defined as a score of \>21 on the Agitated Behavior Scale) or another uncooperative behavior.
• Inability to operate the Armeo system (which will be assessed during the calibration process). Subjects must have sufficient range of movement to enable calibration of the virtual workspace.
• Contraindications for Levodopa/ Carbidopa:
• Hypersensitivity to levodopa, carbidopa or any component of the formulation.
• Narrow-angle glaucoma.
• Suspicious, undiagnosed skin lesions or a history of melanoma.
• Presence of metallic hardware in close contact to the discharging coil (cochlear implants, aneurism clips, brain implants, internal pulse generator, medication pumps).
• Contemporary participation in another interventional trial focused on the impaired arm recovery.

Sponsors & Collaborators

• Ross D. Zafonte, MD: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ross Zafonte, DO

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  STUDY CHAIR

• Duc A Tran, MD PhD

  Spaulding Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 27, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)