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CI Therapy + Sensory Training for Stroke

Q: Does this study include minors as participants?

This trial stipulates that participants range from 18 to 89 years of age. Meanwhile, there are 40 trials for minors and 1019 studies with a focus on seniors.

Q: Has enrollment for this experiment opened yet?

The information hosted on clinicaltrials.gov states that this medical experiment is actively seeking participants. It was first posted and recently updated on March 30th 2023.

Q: Could you provide an estimate of the number of participants in this research project?

Affirmative. The information on clinicaltrials.gov suggests that this experiment is actively seeking participants as of 3/30/2023, with the last update to its post being made at the same time. 12 individuals are required from one healthcare facility for enrolment into this study.

Q: Is it possible for me to be a participant in this research endeavor?

This medical trial is recruiting 12 <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> patients, aged 18 to 89. According to the inclusion criteria, these potential participants must have had a stroke at least 6 months prior and demonstrate minimum movement in their upper extremity. Additionally, they are expected to score less than 2.5 on the Motor Activity Log/ G4/5 Motor Activity Log which evaluates usage of their affected arm.

Q: What outcomes is this medical experiment designed to evaluate?

This clinical trial will monitor patient progress via the Wolf Motor Function Test, Participant Opinion Survey, Revised Nottingham Sensory Assessment and Zung <a href="https://www.withpower.com/clinical-trials/depression">Depression</a> Scale over a 3 month period after treatment. The results of these tests are used to measure outcomes such as motor function improvement, participant sentiment concerning interventions, changes in sensation for upper extremities post-treatment and mood fluctuations respectively.

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The ability to demonstrate the minimum UE active movement criteria of shoulder ≥ 30 toward flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate movement at the wrist, fingers, or thumb.

Mean score of <2.5 on the Motor Activity Log/ G4/5 Motor Activity Log indicating the participant's use of the more-affected UE.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months follow-up after the end of treatment.

Awards & highlights

Study Summary

This trial will investigate if CI Therapy, a rehab method to improve use of the more-affected arm after stroke, can be improved with somatosensory measurement and training.

Who is the study for?

This trial is for adults who've had a stroke at least 6 months ago and have mild-to-severe difficulty moving their arm but can still do some basic movements. They should be able to use the affected arm a little in daily life, as shown by specific test scores.Check my eligibility

What is being tested?

The study tests Constraint-Induced Movement Therapy with added sensory training on people after a stroke. It involves intensive behavioral techniques, motor training, tasks that encourage using the weaker arm, and strategies to improve its everyday use.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include fatigue due to intensive therapy sessions, frustration or emotional distress from challenging exercises, and possible muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can move my shoulder, elbow, wrist, fingers, or thumb a little.

Select...

My use of my weaker arm or hand scores less than 2.5 on a specific test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 month follow up after the end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 month follow up after the end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 month follow up after the end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Canadian Occupational Performance Measure (COPM)

G4/5 Motor Activity Log

G4/5 Motor Activity Log (G4/5 MAL)

+3 more

Secondary outcome measures

Participant Opinion Survey (PO Survey)

Revised Nottingham Sensory Assessment (rNSA)

Semmes-Weinstein Monofilament Test (SWMT)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Grade 2-5 CI Therapy + Sensory ComponentsExperimental Treatment1 Intervention

All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,650 Total Patients Enrolled

36 Trials studying Stroke

87,372 Patients Enrolled for Stroke

David Morris, PhDStudy ChairUniversity of Alabama at Birmingham

1 Previous Clinical Trials

12 Total Patients Enrolled

1 Trials studying Stroke

12 Patients Enrolled for Stroke

Media Library

Constraint-Induced Movement Therapy Plus Sensory Components Clinical Trial Eligibility Overview. Trial Name: NCT05515237 — N/A

Stroke Research Study Groups: Grade 2-5 CI Therapy + Sensory Components

Stroke Clinical Trial 2023: Constraint-Induced Movement Therapy Plus Sensory Components Highlights & Side Effects. Trial Name: NCT05515237 — N/A

Constraint-Induced Movement Therapy Plus Sensory Components 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515237 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include minors as participants?

"This trial stipulates that participants range from 18 to 89 years of age. Meanwhile, there are 40 trials for minors and 1019 studies with a focus on seniors."

Answered by AI

Has enrollment for this experiment opened yet?

"The information hosted on clinicaltrials.gov states that this medical experiment is actively seeking participants. It was first posted and recently updated on March 30th 2023."

Answered by AI

Could you provide an estimate of the number of participants in this research project?

"Affirmative. The information on clinicaltrials.gov suggests that this experiment is actively seeking participants as of 3/30/2023, with the last update to its post being made at the same time. 12 individuals are required from one healthcare facility for enrolment into this study."

Answered by AI

Is it possible for me to be a participant in this research endeavor?

"This medical trial is recruiting 12 stroke patients, aged 18 to 89. According to the inclusion criteria, these potential participants must have had a stroke at least 6 months prior and demonstrate minimum movement in their upper extremity. Additionally, they are expected to score less than 2.5 on the Motor Activity Log/ G4/5 Motor Activity Log which evaluates usage of their affected arm."

Answered by AI

What outcomes is this medical experiment designed to evaluate?

"This clinical trial will monitor patient progress via the Wolf Motor Function Test, Participant Opinion Survey, Revised Nottingham Sensory Assessment and Zung Depression Scale over a 3 month period after treatment. The results of these tests are used to measure outcomes such as motor function improvement, participant sentiment concerning interventions, changes in sensation for upper extremities post-treatment and mood fluctuations respectively."

Answered by AI

Recent research and studies

CirculationJournal

Heart Disease and Stroke Statistics—2022 Update: A Report from the American Heart Association

Tsao, Connie W., Aaron W. Aday, Zaid I. Almarzooq, Alvaro Alonso, Andrea Z. Beaton, Marcio S. Bittencourt, Amelia K. Boehme, et al.. 2022. “Heart Disease and Stroke Statistics—2022 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000001052.

Neurorehabilitation and Neural RepairJournal

Rehabilitation of Reaching and Grasping Function in Severe Hemiplegic Patients Using Functional Electrical Stimulation Therapy

Thrasher, T. Adam, Vera Zivanovic, William McIlroy, and Milos R. Popovic. 2008. “Rehabilitation of Reaching and Grasping Function in Severe Hemiplegic Patients Using Functional Electrical Stimulation Therapy”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968308317436.

Archives of Physical Medicine and RehabilitationJournal

The Reliability of the Wolf Motor Function Test for Assessing Upper Extremity Function After Stroke

Morris, David M., Gitendra Uswatte, Jean E. Crago, Edwin W. Cook III, and Edward Taub. 2001. “The Reliability of the Wolf Motor Function Test for Assessing Upper Extremity Function After Stroke”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1053/apmr.2001.23183.

Journal of the Experimental Analysis of BehaviorJournal