Supported Reaching + Abduction Loading for Stroke

(PRALINE Trial)

Not currently recruiting at 2 trial locations

Overseen By Michael D Ellis, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Chronic neurological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people who have had a recent stroke improve arm movement. After a stroke, some individuals struggle with reaching outward due to a movement issue called "flexion synergy." The trial will test two therapies: one involves practicing reaching with added weight (abduction loading), and the other involves reaching with support (supported reaching). Ideal candidates for this trial are those who have experienced a stroke affecting one side of the brain within the last 90 days and have mild language or attention issues. Participants will continue their usual therapies while trying one of these new methods. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that progressive abduction loading therapy is generally safe for stroke patients, with studies identifying no specific safety concerns. This therapy includes exercises to help regain arm movement after a stroke, aiming to improve the ability to reach out by practicing with added weight. Patients typically handle this therapy well.

For the supported reaching approach, no safety issues have been reported. This method involves practicing reaching movements with support to enhance arm function. Both approaches focus on improving movement and are considered safe based on previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Supported Reaching + Abduction Loading approach for stroke rehabilitation because it focuses on innovative movement techniques that differ from traditional therapies. Unlike standard rehabilitation methods that often involve repetitive exercises to regain strength and coordination, this approach incorporates abduction loading and supported reaching, which specifically target muscle activation and control during reaching tasks. By challenging the muscles in new ways, these techniques could potentially enhance motor recovery and offer more precise improvements in arm function for stroke patients.

What evidence suggests that this trial's treatments could be effective for minimizing flexion synergy after stroke?

This trial will compare two techniques for improving arm movement after a stroke: abduction loading and supported reaching. Research has shown that abduction loading, which participants in one arm of this trial will practice, can enhance arm movement by improving control of arm joints, making it easier to reach out. Early research discovered that abduction loading during reaching exercises boosts arm function, especially for those with long-term stroke conditions.

Participants in another arm of this trial will practice supported reaching, which has been shown to increase muscle activity in the arm. This method enhances arm muscle function by supporting the arm against gravity as it moves. Both techniques aim to improve movement and strength in the arms, aiding recovery after a stroke. ^{1 2 5 6 7}

Who Is on the Research Team?

Michael D Ellis, PT, DPT

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who've had a stroke within the last 90 days, can consent to participate, and have mild-to-moderate difficulty with language. They should have weakness on one side of their body but be able to follow simple commands with their unaffected arm. People with pre-existing disabilities in their arms, certain brain lesions, medical conditions that limit movement assessments, chronic neurological issues other than stroke, or pain that affects movement cannot join.

Inclusion Criteria

I have weakness on one side of my body.

You have no or slight problems with paying attention and noticing things.

I can follow a 3-step command with my arm that is not affected.

Exclusion Criteria

I have long-term difficulty using my arms or hands.

I have a tumor in my brainstem or cerebellum.

I experience pain or sensitivity that affects my ability to move.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

In-patient Rehabilitation

Participants receive experimental or comparison group therapy as adjuvant to regular in-patient therapy. Sessions are conducted 5 days per week.

4-10 weeks

5 visits per week (in-person)

Day Rehabilitation

Participants continue to receive the same study intervention 3 days per week during day-rehabilitation.

4-10 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with evaluations bimonthly until 12 months post-baseline.

12 months

Bimonthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abduction Loading
• Supported Reaching

Trial Overview The study tests two therapies aimed at improving arm reach after a stroke by preventing 'flexion synergy,' which restricts outward arm movement. Participants will receive either Supported Reaching or Abduction Loading therapy along with standard rehab treatments over a year and will be monitored to see which method is more effective.

How Is the Trial Designed?

Group I: Abduction Loading Experimental Treatment 1 Intervention

The intervention for the experimental group entails practicing reaching with abduction loading.

Group II: Supported Reaching Active Control 1 Intervention

The intervention for the active comparator entails practicing reaching while supported.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Marianjoy Rehabilitation Hospital & Clinics

Collaborator

Trials

2

Recruited

90+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Published Research Related to This Trial

In a study involving 28 participants with post-stroke hemiparesis, it was found that reaching performance varies significantly based on the direction of the movement, with individuals showing poorer performance in the anteroposterior direction regardless of their motor recovery status.

Participants with moderate-to-severe hemiparesis initially showed less movement in the anteroposterior direction, but this bias decreased as they recovered, indicating that rehabilitation should consider direction-specific training to improve reaching abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direction-dependent differences in the quality and quantity of horizontal reaching in people after stroke. Uehara, S., Yuasa, A., Ushizawa, K., et al.[2023]

In a study involving 26 right-handed patients with their first stroke, training the elbow extensors in an antigravity position significantly improved upper extremity function and range of motion compared to traditional exercises.

Task-specific training over 16 weeks led to notable enhancements in manual dexterity and overall upper limb function, as measured by the Nine-Hole Peg Test and Fugl-Meyer assessment, indicating its effectiveness in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Gravity and Task Specific Training of Elbow Extensors on Upper Extremity Function after Stroke. Khallaf, ME.[2022]

A robotic system called ACT(3D) was used in a study with 8 chronic stroke survivors to quantitatively measure and improve abnormal joint torque coupling through progressive shoulder abduction loading over 8 weeks.

The intervention significantly increased the reaching work area of participants, indicating that targeting joint torque coupling can effectively enhance reaching abilities after a stroke, even without changes in single-joint strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impairment-Based 3-D Robotic Intervention Improves Upper Extremity Work Area in Chronic Stroke: Targeting Abnormal Joint Torque Coupling With Progressive Shoulder Abduction Loading. Ellis, MD., Sukal-Moulton, TM., Dewald, JP.[2022]

The ACT3D robotic system effectively records movement patterns in stroke patients, revealing that increased shoulder abduction torque leads to reduced elbow extension and shoulder flexion capabilities.

Preliminary data suggest that targeted training interventions can help stroke patients improve their reaching abilities by addressing abnormal joint torque coupling during movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Source of work area reduction following hemiparetic stroke and preliminary intervention using the ACT3D system. Sukal, TM., Ellis, MD., Dewald, JP.[2020]

In a study involving 12 chronic stroke subjects, task-related training (TRT) was found to be more beneficial for low-functioning individuals, improving their arm coordination and reducing compensatory trunk movements during reaching tasks.

High-functioning subjects showed less compensatory trunk use after progressive resistive exercise (PRE), indicating that their movement patterns were closer to normal, but no significant differences in kinematic outcomes were observed between the two training approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of reaching after stroke: task-related training versus progressive resistive exercise. Thielman, GT., Dean, CM., Gentile, AM.[2019]

A study involving 47 stroke patients found that both sling-constraint and voluntary-constraint therapies were equally effective in improving arm function after intensive rehabilitation, with no significant differences in outcomes between the two methods.

Patients maintained their improvements in arm use for at least 12 months after treatment, indicating that both constraint methods can lead to lasting benefits in functional arm use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sling and voluntary constraint during constraint-induced movement therapy for the arm after stroke: a randomized, prospective, single-centre, blinded observer rated study. Krawczyk, M., Sidaway, M., Radwanska, A., et al.[2016]

In a study of 32 individuals with chronic hemiparetic stroke, both groups showed significant improvements in reaching distance (13.2%) and velocity (13.6%) after 8 weeks of therapy, indicating that progressive abduction loading therapy is effective for enhancing reaching function.

Adding horizontal-plane viscous resistance did not provide additional benefits for improving reaching function, suggesting that targeting flexion synergy through abduction loading alone is sufficient for rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Abduction Loading Therapy with Horizontal-Plane Viscous Resistance Targeting Weakness and Flexion Synergy to Treat Upper Limb Function in Chronic Hemiparetic Stroke: A Randomized Clinical Trial. Ellis, MD., Carmona, C., Drogos, J., et al.[2022]

A study involving 31 participants with severe stroke demonstrated significant improvements in both reaching distance and peak reaching velocity after undergoing targeted rehabilitation robotics with progressive abduction loading therapy.

This research highlights the potential of progressive abduction loading as an effective rehabilitation strategy for restoring function in individuals with chronic stroke, addressing the common issue of impaired joint control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive abduction loading therapy targeting flexion synergy to regain reaching function in chronic stroke: Preliminary results from an RCT. Ellis, MD., Carmona, C., Drogos, J., et al.[2020]

In a study involving 11 hemiparetic stroke patients, trunk restraint therapy significantly improved upper limb function, as evidenced by notable changes in the Fugl-Meyer Assessment Scale and Barthel Index after treatment and at a 3-month follow-up.

The therapy helped patients utilize their existing but underused arm joint ranges, suggesting that trunk restraint can effectively reveal and enhance latent movement patterns for better arm recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in the upper limb of hemiparetic patients after reaching movements training. de Oliveira, R., Cacho, EW., Borges, G.[2016]

In a clinical trial with eight chronic stroke patients, gravity compensation training led to a significant improvement in maximal reach distance by 3.5% of arm length and increased elbow extension by 9.2° after 18 sessions over 6 weeks.

The training also resulted in a 68% increase in elbow extensor muscle activity, suggesting that gravity compensation can effectively enhance muscle activation and improve arm function in stroke rehabilitation without requiring advanced technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in muscle activation after reach training with gravity compensation in chronic stroke patients. Prange, GB., Krabben, T., Renzenbrink, GJ., et al.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40685355/

study protocol for a phase IIb inpatient stroke rehabilitation ... Emerging evidence demonstrates improved independent upper extremity joint movement with training combining shoulder abduction loading during ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04118998

NCT04118998 | Progressive Abduction Loading Therapy This study attempts to minimize the development of a common movement impairment following stroke known as "flexion synergy" that makes it extremely ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08969-6

PRALINE: study protocol for a phase IIb inpatient stroke ... Reaching exercise with progressive shoulder abduction loading has been shown to ameliorate the loss of independent joint control and improve ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2018.00071/full

Progressive Abduction Loading Therapy with Horizontal- ... Preclinical investigations have identified abduction loading during reaching exercise as a key therapeutic factor to improve reaching function.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2833097/

Progressive Shoulder Abduction Loading is a Crucial Element ... This study demonstrated that functionally relevant reaching range of motion (work area) can be improved in individuals with chronic hemiparetic stroke and, most ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29515514/

Progressive Abduction Loading Therapy with Horizontal ... Progressive abduction loading therapy has emerged as a promising exercise therapy in stroke rehabilitation to systematically target the loss of independent ...

7. researchgate.net researchgate.net/publication/393850829_PRALINE_study_protocol_for_a_phase_IIb_inpatient_stroke_rehabilitation_randomized_controlled_trial_investigating_longitudinal_outcomes_after_progressive_abduction_loading_therapy

PRALINE: study protocol for a phase IIb inpatient stroke ... Discussion This study will test the efficacy of progressive shoulder abduction loading during reaching training using a mechatronic device. The ...