MedTrace Logo

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

NCT02346630 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-12-27

No results posted yet for this study

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

Interventions

DRUG

Placebo

Placebo capsules daily for 3 weeks.

DRUG

Levodopa / Carbidopa

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

DEVICE

Armeo

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

Sponsors & Collaborators

  • Ross D. Zafonte, MD

    lead OTHER

Principal Investigators

  • Ross Zafonte, DO · Harvard Medical School (HMS and HSDM)

  • Paolo Bonato, PhD · Spaulding Rehabilitation Hospital

  • Duc A Tran, MD PhD · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346630 on ClinicalTrials.gov