Assessment of a Upper Limb Robotic Device in Stroke Patients

Stroke Clinical Trial

Official title:

Assessment of a Upper Limb Robotic Device in Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03469778
• Other study ID #: 71611217.5.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2018
• Last updated: March 12, 2018
• Start date: May 2, 2018
• Est. completion date: September 2018

Study information

• Verified date: December 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inlcusion Criteria:

1. Between 40 and 65 years.

2. Both genders.

3. Clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery.

4. Clinical assessment of disability with diagnosis of right or left hemiparesis.

5. Onset between 24 and 36 months.

6. Clinical stability verified in medical evaluation.

7. Spasticity less than or equal to 2 in Modified Ashworth Scale.

8. Moderate motor impairment in upper limb, according to Fugl-Meyer Assessment Upper Limb score (34 to 55 points).

9. To remain seated in a backrest chair during the intervention period (about 55 minutes).

10. Acceptance of informed consent form to participate in the study.

Exclusion Criteria:

1. Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.

2. Progressive worsening of spasticity.

3. Withdrawal of the informed consent form.

4. New episode of stroke.

5. Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robotic Therapy
Robotic Therapy

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical feasibility	Time necessary to adjust the device; patients satisfaction questionnaire.	Reported during 6 weeks treatment, in each session.
Primary	Fugl Meyer Assessment Upper Limb (FMA-UL)	FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand.	Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary	Wolf Motor Function Test (WMFT)	WMFT evaluates time performance and functional ability in 17 unimanual tasks.	Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary	Dynamometry - Grasp and Pinch	Instrument to measure palmar and lateral grip (strength in kgf).	Mean change from baseline at six weeks (19 sessions of robotic therapy).
Secondary	Patients safety	Adverse effects questionnaire applied in each session.	Adverse effects reported during 6 weeks treatment.
Secondary	Treatment adherence	Number of patients withdrawing from treatment without justification (drop outs).	Drop outs reported during 6 weeks treatment.