Isometric Reaching for Stroke

Overseen By Courtney Celian, OTR/L

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Severe medical problems, Visual deficits, High blood pressure, Low blood oxygen, others

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

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how 3D isometric movement training, an exercise where muscles engage without movement, can benefit stroke survivors. Participants will be divided into two groups: one will practice isometric reaching using a robotic setup, while the other will move freely without intervention. The trial seeks individuals who experienced a stroke at least 8 months ago and have some movement in their shoulder and elbow. As an Early Phase 1 trial, this research focuses on understanding how this innovative exercise treatment functions in people, offering participants a chance to contribute to groundbreaking stroke recovery methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving Botox or other botulinum toxin injections, you must not have had them in the affected upper extremity within the previous 4 months.

What prior data suggests that this isometric reaching technique is safe for stroke patients?

Research shows that isometric reaching, a type of movement training, is under study for aiding arm recovery after a stroke. It aims to enhance movement skills. Although specific safety information about isometric reaching in humans is limited, the treatment is in early testing stages. Researchers are primarily assessing its safety and potential side effects.

Early trials focus on participants' tolerance of the treatment. If it posed significant risks, it likely wouldn't have advanced to this stage. Since researchers compare isometric reaching to other rehabilitation methods, the risk is considered low. This suggests the treatment is likely safe for most people, but more detailed information will emerge as research progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Isometric Reaching for stroke rehabilitation because it introduces a novel approach by using a robotic system that provides resistance, simulating arm movements based on the forces applied by the patient. Unlike traditional therapies, which often involve free arm movement and focus primarily on repetitive motion exercises, this technique allows patients to engage in controlled, isometric exercises that may enhance muscle strength and coordination. This innovative method could potentially lead to more effective and faster recovery by uniquely targeting neuromuscular pathways, offering a promising complement to existing stroke rehabilitation options.

What evidence suggests that isometric reaching is effective for stroke?

Studies have shown that isometric movement training can enhance arm function after a stroke by improving movement skills. Research suggests that most motor improvement occurs soon after a stroke, typically within the first three months. This trial will compare two approaches: the Isometric Reaching condition, where participants apply forces on a robot handle to drive a reaching arm simulation, and the Control Reaching condition, where participants move toward the target freely with visual feedback based on hand position. This therapy builds strength without moving the arm, aiding stroke recovery. Early rehabilitation exercises, such as isometric reaching, have been proven to improve arm strength and function. Evidence supports starting these exercises soon after a stroke for better results. ^{1 6 7 8 9}

Who Is on the Research Team?

James L Patton, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are either healthy or have had a stroke. Participants must be able to understand and agree to the study's procedures by giving informed consent. People with a history of stroke can't join if they're considered neurotypical, meaning they don't currently have any impairments from a stroke.

Inclusion Criteria

Neurotypical participants must have the ability to provide informed consent

I am at least 18 years old and have had a stroke.

I have medical records and scans showing where my stroke affected my brain.

Exclusion Criteria

I can hold positions needed for tests.

Stroke participants must not be rated below 15 on the FMUE scale

Stroke participants must not be concurrently participating in upper extremity rehabilitation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants practice a unilateral virtual reality targeted reaching task using a robotic arm in a 3D visual display system.

12 months

Regular sessions (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Isometric Reaching

Trial Overview

The IsoReach trial is testing how effective 3D isometric movement training is for people who are healthy and those impaired by a stroke. The goal is to see if this type of exercise can improve their ability to reach and move in three dimensions.

How Is the Trial Designed?

Group I: Isometric Reaching condition Experimental Treatment 1 Intervention

In this arm the participant participates in "Isometric Reaching" in which they are not allowed to freely reach to the target, instead the forces they apply on the robot handle drives a reaching arm simulation

Group II: Control Reaching condition Active Control 1 Intervention

In this condition the participant moves toward target freely and the visual feedback is based on hand position and not an arm simulation.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Stroke survivors exhibit significant kinematic differences compared to healthy adults during reach-to-target tasks, including longer movement times, lower peak velocities, and greater trunk displacement, indicating specific areas where rehabilitation can be focused.

The meta-analysis of 32 studies involving 618 stroke patients and 429 healthy adults revealed that stroke survivors also show delayed muscle activation and reduced coordination, suggesting that tailored interventions could enhance upper limb recovery by addressing these deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic Components of the Reach-to-Target Movement After Stroke for Focused Rehabilitation Interventions: Systematic Review and Meta-Analysis. Collins, KC., Kennedy, NC., Clark, A., et al.[2020]

The study followed 15 stroke patients for up to 32 weeks and found that loss of independent joint control can be detected as early as 2 weeks post-stroke, highlighting the importance of early assessment in recovery.

Patients with mild strokes showed a rapid recovery, while those with severe strokes experienced persistent impairments, suggesting that targeted interventions, especially robotic rehabilitation, could be beneficial for those with significant joint control loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying loss of independent joint control in acute stroke with a robotic evaluation of reaching workspace. Ellis, MD., Kottink, AI., Prange, GB., et al.[2022]

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]

A meta-analysis of 29 studies involving 460 individuals with stroke and 324 control participants revealed significant kinematic differences in reach-to-grasp movements, with stroke survivors showing lower peak velocity and greater trunk displacement compared to controls.

The study suggests that the location of objects affects kinematic characteristics during reach-to-grasp tasks, indicating that rehabilitation strategies should consider object placement to improve motor function in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting a kinematic handle on reach-to-grasp: a meta-analysis. Collins, KC., Kennedy, NC., Clark, A., et al.[2018]

In a study involving 8 chronic stroke participants and 10 control participants, it was found that when using their more impaired upper limb, stroke patients showed decreased success and accuracy in reaching tasks, along with altered eye movement patterns, such as increased focus on the limb itself.

Providing support to the impaired upper limb improved hand-eye coordination in stroke patients, making their eye movement patterns more similar to those of control participants, suggesting that rehabilitation strategies should incorporate upper limb support to enhance motor and oculomotor performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper limb and eye movement coordination during reaching tasks in people with stroke. Meadmore, KL., Exell, TA., Burridge, JH., et al.[2018]

In a study of 17 stroke survivors, it was found that reaching with the stroke-affected side involved less shoulder and elbow range of motion, and more trunk flexion compared to the less-affected side, indicating altered movement patterns post-stroke.

While there were few differences in kinematics between discrete and cyclic reaching tasks on the stroke-affected side, cyclic reaching required greater trunk rotation, suggesting a unique strategy that could inform rehabilitation approaches focusing on continuous movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical contributions of the trunk and upper extremity in discrete versus cyclic reaching in survivors of stroke. Massie, CL., Malcolm, MP., Greene, DP., et al.[2016]

The Oblique Direction Reach Test (ODRT) is a highly valid and reliable method for assessing balance in stroke patients, showing strong correlations with established balance measures like the Berg Balance Scale (r = 0.905).

In a study involving 96 first-time stroke patients, it was found that these individuals reached significantly shorter distances in the ODRT compared to healthy controls, indicating impaired stability and balance post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oblique direction reach test: evaluating psychometric properties in stroke population. Mascarenhas, R., Nayak, A., Joshua, AM., et al.[2023]

In a study of 10 stroke survivors with mild hand paresis, significant differences in hand shape modulation were observed during grasping tasks compared to healthy controls, particularly in the final phase of grasping where fine adjustments are made.

The analysis of palmar arch modulation revealed that stroke survivors required more time and effort to adjust their hand shape during grasping, indicating the need for targeted rehabilitation strategies to improve their motor recovery and reduce compensatory movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palmar arch modulation in patients with hemiparesis after a stroke. Sangole, AP., Levin, MF.[2021]

A machine learning system successfully detected compensatory movements in stroke patients with high accuracy (average F1-score over 0.95), demonstrating the feasibility of using pressure distribution data for real-time monitoring.

Real-time feedback significantly reduced compensatory behaviors in stroke patients, with force feedback proving to be more effective than audiovisual feedback in promoting proper movement patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online compensation detecting for real-time reduction of compensatory motions during reaching: a pilot study with stroke survivors. Cai, S., Wei, X., Su, E., et al.[2020]

The study found that intrinsic factors, such as the participant's reach distance and the weight of the power drill, were better predictors of how they transitioned between using just their arms or involving their torso during a seated reach task.

Discomfort levels and muscle activation, particularly in the upper trapezius, also played significant roles in determining how participants adjusted their movements to effectively use the power drill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of object weight, reach distance, discomfort and muscle activation on the location of preferred critical boundary during a seated reaching task. Petrovic, M., Berg, WP., Mark, LS., et al.[2018]

In a study of 12 individuals with chronic stroke, specific arm movement control strategies were identified that correlated with the level of upper limb impairment and functional improvement after bilateral arm training.

The findings suggest that improving the coordination between shoulder and elbow movements could enhance recovery outcomes, as better shoulder control was linked to less impairment and faster functional task performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory arm reaching strategies after stroke: induced position analysis. Liu, W., McCombe Waller, S., Kepple, TM., et al.[2021]

In a study involving 18 stroke patients and 18 control participants, reaching for targets beyond arm's length significantly altered arm and trunk movements, indicating that distance affects motor control in stroke patients.

The results suggest that therapists should consider restraining trunk movements during reaching exercises to prevent asymmetrical movements and improve rehabilitation outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic Manifestation of Arm-Trunk Performance during Symmetric Bilateral Reaching After Stroke: Within vs. Beyond Arm's Length. Ma, HI., Lin, KC., Hsieh, FH., et al.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8767646/

Movement therapy without moving – first results on isometric ...

This study explores the use of isometric movement training for arm rehabilitation after stroke. The aim of this approach is to enhance movement skill.

2.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1442120/full

Improvements in upper extremity isometric muscle strength ...

Most motor recovery occurs early, typically plateauing around 3 months after stroke (16–18), due to processes of motor control and learning that ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/strokeaha.122.041098

Rehabilitation Therapy Doses Are Low After Stroke and ...

Therapy counts were low overall, with most therapy delivered within the first 3 months; 35.0% of patients received no physical therapy; 48.8%, ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S105230572500268X

A Real-World Propensity-Matched Cohort Study

The primary outcome was improvement in upper-limb motor function during the inpatient rehabilitation period, assessed by the change in Fugl- ...

5.

mdpi.com

mdpi.com/1660-4601/19/19/12739

Effectiveness of Rehabilitation Exercise in Improving ...

In particular, studies show that applying rehabilitation exercise early after stroke is effective [11].

6.

ahajournals.org

ahajournals.org/doi/10.1161/strokeaha.116.015147

Impact of Rehabilitation on Outcomes in Patients With ...

The present results suggested that early and intensive rehabilitation improved ADL during hospitalization in patients with ischemic stroke.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10216461/

A Comprehensive Review of Physical Therapy Interventions ...

The study found that VR training was equally as effective as CT in improving upper extremity function during the subacute phase after a stroke.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1836955318301152

Interventions involving repetitive practice improve strength ...

Each study was rated as high risk, unclear risk or low risk on the following domains: sequence generation; concealed allocation; blinding of participants and ...

9.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1423517/full

Efficacy and safety of very early rehabilitation for acute ...

This meta-analysis proved that VER could elevate the risk of death after stroke and stroke severity during hospitalization. However, it significantly lowered ...