Supported Reaching + Abduction Loading for Stroke

(PRALINE Trial)

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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

This study attempts to minimize the development of a common movement impairment following stroke known as "flexion synergy" that makes it extremely difficult to reach outward with the arm. Participants with acute/subacute stroke will receive one of two study interventions in addition to prescribed therapies in both inpatient rehabilitation and day-rehab. Participants will be followed for 1 year.

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 data supports the effectiveness of the treatment Supported Reaching + Abduction Loading for Stroke?

Research shows that progressive abduction loading therapy, which is part of this treatment, helps improve arm movement in stroke patients by targeting muscle weakness and improving joint control. Studies found significant improvements in reaching distance and speed, suggesting this approach can effectively enhance arm function after a stroke. ^{1 2 3 4 5}

Is Supported Reaching + Abduction Loading therapy safe for humans?

The studies on Progressive Abduction Loading Therapy for stroke patients do not report any specific safety concerns, suggesting it is generally safe for human use in this context. ^{2 3 4 6 7}

How does the treatment 'Supported Reaching + Abduction Loading' differ from other stroke treatments?

This treatment is unique because it combines progressive abduction loading with resistance training to specifically target and improve reaching function in stroke patients by addressing flexion synergy (abnormal muscle coordination) and muscle weakness, which are not typically the focus of standard stroke rehabilitation therapies. ^{3 4 8 9 10}

Research Team

Michael D Ellis, PT, DPT

Principal Investigator

Northwestern University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Changes in muscle activation after reach training with gravity compensation in chronic stroke patients. [2016]

2. United States 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. [2022]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Progressive abduction loading therapy targeting flexion synergy to regain reaching function in chronic stroke: Preliminary results from an RCT. [2020]

5. England 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. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Source of work area reduction following hemiparetic stroke and preliminary intervention using the ACT3D system. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Improvements in the upper limb of hemiparetic patients after reaching movements training. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Direction-dependent differences in the quality and quantity of horizontal reaching in people after stroke. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of reaching after stroke: task-related training versus progressive resistive exercise. [2019]