Finger Movement Training for Stroke

N/A

Recruiting

Research Sponsored by North Carolina State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change of value from before the intervention to immediately after the intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess a new rehab intervention combining electrical stimulation + soft exoskeleton to improve hand function after stroke.

Who is the study for?

This trial is for stroke survivors who are 2-6 months post-stroke, can consent, see shapes on a screen, and have moderate to mild hand impairment without severe pain or joint issues that would prevent movement.

What is being tested?

The study tests a new therapy combining electrical nerve stimulation with a soft hand exoskeleton (AVK system) to improve finger movement. Participants will undergo 15 training sessions over 5 weeks with evaluations before, during, after training, and one month later.

What are the potential side effects?

Potential side effects may include discomfort from the electrical stimulation or exoskeleton use. Muscle fatigue and soreness could occur due to repetitive movements during the training sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change of value from before the intervention to immediately after the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change of value from before the intervention to immediately after the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change of value from before the intervention to immediately after the intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of Jebsen-Taylor Hand Function Test (JTHFT)

Secondary study objectives

Change of 3-point pinch strength

Change of 9-Hole Peg Test (9PHT)

Change of Box and Blocks Test (BBT)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Functional electrical stimulation (FES) + AVK groupExperimental Treatment1 Intervention

This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.

Group II: OT GroupActive Control1 Intervention

An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.

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