50 Participants NeededMy employer runs this trial

Arm Basis Training for Stroke Rehabilitation

(SPARk Trial)

JD
CL
Overseen ByCaroline Lambert, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specific arm therapy can improve movement after a stroke and alter brain pathways. Participants will receive either intensive Arm Basis Training (a specialized arm therapy) or usual therapy to determine which is more effective. It targets individuals who experienced a stroke in the last 3-6 months and still struggle with arm movement. The goal is to better understand and improve treatments for stroke-related arm movement issues. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for stroke rehabilitation?

Research shows that intensive rehabilitation, such as Arm Basis Training, can improve arm movement in stroke patients. Studies have found that this therapy is usually well-tolerated. For example, one study reported that only 3% of participants stopped the therapy early, indicating that most people can manage the training without major problems. This therapy has been linked to better arm movement, suggesting it might help patients move their arms more easily after a stroke. While specific safety information for Arm Basis Training might be limited, evidence from similar therapies suggests it is safe for most people.12345

Why are researchers excited about this trial?

Unlike the standard care options for stroke rehabilitation, which often include traditional occupational therapy, Arm Basis Training is unique because it focuses on systematically improving motor control at a fundamental level. This experimental method specifically targets the proximal motor control, aiming to rebuild a patient's ability to perform specific, selective movements before advancing to more complex patterns. Researchers are excited about this approach because it offers the potential to enhance motor function in patients with severe upper extremity hemiparesis, which could lead to more effective recovery outcomes than conventional therapies.

What evidence suggests that Arm Basis Training is effective for stroke rehabilitation?

Studies have shown that intensive arm exercises can greatly improve arm function after a stroke. Research indicates that Bilateral Arm Training (BAT), which involves using both arms simultaneously, leads to better movement improvements compared to other therapies. For example, a review of several studies found that BAT significantly enhanced arm movement skills, especially in stroke recovery patients. Another study demonstrated that more intense arm exercises could further boost movement abilities. This trial will compare Arm Basis Training, a focused and intensive arm exercise regimen, with usual care occupational therapy to evaluate its effectiveness in improving arm movement and control after a stroke.678910

Who Is on the Research Team?

DJ

David J Lin, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people who had their first stroke (either ischemic or hemorrhagic) on one side of the brain within the past 3-6 months, have moderate to severe arm weakness, and can take part in a 6-week intensive therapy program in English.

Inclusion Criteria

I had my first stroke between 3 to 6 months ago.
My arm and hand movement is limited, scoring 44 or less on a specific test.
I can join a 6-week arm therapy program in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 30 hours over 6 weeks of Arm Basis Training or usual care occupational therapy

6 weeks
Regular in-person therapy sessions

Assessment

Kinematic motor assessments, neuroimaging, and neurophysiology are performed before and after therapy

Pre- and post-therapy
2 visits (in-person)

Follow-up

Participants are monitored for changes in motor control and brain pathways post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Arm Basis Training

Trial Overview

The study compares an intensive arm training program called Arm Basis Training (30 hours over 6 weeks) with usual care. It aims to see how this targeted therapy affects arm movement and changes in the brain after stroke.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm Basis TrainingExperimental Treatment1 Intervention
Group II: Usual Care Occupational TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Effectiveness and Success Factors of Bilateral Arm Training ...

Our meta-analysis indicates that BAT may be more beneficial than CT in addressing post-stroke UL motor impairment, particularly in the chronic phase with mild ...

Effectiveness and Success Factors of Bilateral Arm Training ...

With 25 RCTs meeting the inclusion criteria, BAT demonstrated significantly greater improvements in motor impairments as measured by Fugl-Meyer.

Most Effective Interventions for Improving Upper Extremity ...

Bilateral Arm Training has been shown to play a significant role in improving upper extremity function in patients with hemiparesis following a stroke.

Improving Upper-Limb Recovery in Patients with Chronic ...

This study evaluated the efficacy of the Arm Booster, a bilateral arm-training device, in improving upper-limb impairment in patients with chronic stroke.

Strength Training Improves Upper-Limb Function in ...

Conclusions—There is evidence that strength training can improve upper-limb strength and function without increasing tone or pain in individuals with stroke. ( ...

Resistive strength training for arm rehabilitation after stroke

Although strength training potentially impacts arm and hand movements after stroke, the present data is heterogeneous and insufficient for evidence‐based ...

Effects of Strength Training on Upper-Limb Function in Post ...

In this proposal, we will use a controlled, randomized, double blind clinical trial to study the effects of shoulder and elbow strength training ...

Arm Rehabilitation - Clinical Pathways in Stroke ... - NCBI

This chapter gives insight into the current evidence for therapy to improve (sensori)motor control and function of the affected arm and hand.

Efficacy of Robot-assisted Training on Upper Limb Motor ...

The current evidence showed that RAT combined with routine rehabilitation therapy can effectively improve the upper limb motor function and activities of daily ...

Effects of physical therapy-based rehabilitation on recovery of ...

The results showed that physical therapy-based rehabilitation training during the recovery period of stroke patients with hemiplegia improves upper limb ...