Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Stroke Clinical Trial

Official title:

Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338971
• Other study ID #: Ipsihand Use in Chronic Stroke
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: October 9, 2020

Study information

• Verified date: December 2021
• Source: Neurolutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.

Description:

Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 9, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 6-months or more post stroke

• Presentation of upper extremity hemiparesis or hemiplegia

• Participants must english speaking

• Demonstrate intact cognition to provide informed consent

• Botox injections are allowed, and must continue regimen at regular intervals throughout the study

Exclusion Criteria -

• Not active in another clinical study

• Not receiving formal therapy for the upper extremity

• No use of other modalities or technologies to the upper extremity

• Cognitive Impairment: Short Blessed Test Score 9 or above

• Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow

• Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally

• Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• IpsiHand Therapy
The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.

Locations

Country	Name	City	State
United States	Neurolutions	Saint Louis	Missouri
United States	Neurolutions	Santa Cruz	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurolutions, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26. — View Citation

Cervera MA, Soekadar SR, Ushiba J, Millán JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May. Review. — View Citation

Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment - Upper Extremity	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.	"Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.
Secondary	Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks	The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points	Change in AMAT score (points) from Baseline to 12 Weeks