Restoring Grasp Ability in Stroke Survivors Through MI-Based Training

North Carolina State University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Behavioral: Standard hand exercise therapy; Behavioral: Neurofeedback - based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06307834

26760

24POST1194772 (Other Grant/Funding Number)

Details and patient eligibility

About

Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.

This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 - 80 years
2. Stroke-induced hand disability in one hand
3. Experienced first stroke at least 6-month prior
4. Difficulty in opening the hand & grasping objects (Stage of Hand 4 or 5 on the Chedoke-McMaster Stroke Assessment (CMSA))
5. Ability to distinguish specific shapes and colors on a computer screen

Exclusion criteria

1. Inability to provide informed consent
2. Suffering from severe pain in the shoulder or hand
3. Having rigid contractures in the joints of the upper limbs, or orthopedic issues that prevent joint movement
4. Presence of non-stroke neurological diseases
5. Presence of severe cognitive deficits, such as unilateral spatial neglect or aphasia
6. Experience of hand disability due to reasons other than stroke
7. Having other serious medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Neurofeedback - based therapy group

Experimental group

Description:

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. Participants will be trained in modulating their brain activation patterns by using Mental Imagery (MI) involving various hand movements. EEG will be used to record brain responses. A visual feedback will be provided during the training to help achieve specific changes in brain responses. Once an appropriate brain response is achieved, an EMG-controlled hand exoskeleton will aid in opening and closing the hand.

Treatment:

Behavioral: Neurofeedback - based therapy

Standard Hand exercises therapy group

Active Comparator group

Description:

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. At each session, participants will practice a particular set of hand exercises. In this intervention, a variety of games, tasks, and movements will be used to improve grasping abilities. These exercises will be personalized according to each participant's interests, which will be identified through the Canadian Occupational Performance Measure and will be guided by study personnel.

Treatment:

Behavioral: Standard hand exercise therapy