Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604143
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Stroke Motor Recovery for the Hand and Fingers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Discovering the Potential for Motor Recovery in People Living with Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare two rehabilitation methods to improve finger movements in people who have had a stroke The main question it aims to answer is which of these two training methods leads to the most improvement
1 Teaching people to reach their movement goals using any strategies they like
2 Teaching people to improve their movement technique and avoid compensatory strategies
There is no one-size-fits-all approach The second goal is to find out who might benefit more from each method Some people with stroke may rely on compensatory strategies due to severe impairment while others with milder strokes might benefit more from techniques that enhance movement quality
The third goal is to take pictures of the brain to see how it changes with each method This will help researchers understand how the brain adapts after a stroke and could lead to treatments that target the brain directly
Participants will
1 Visit the lab for clinical and research assessments on weeks 1 4 5 and 15
2 Complete 10 days of piano training
3 Undergo magnetic resonance imaging MRI scans twice once in week 1 and once in week 4
1 Teaching people to reach their movement goals using any strategies they like
2 Teaching people to improve their movement technique and avoid compensatory strategies
There is no one-size-fits-all approach The second goal is to find out who might benefit more from each method Some people with stroke may rely on compensatory strategies due to severe impairment while others with milder strokes might benefit more from techniques that enhance movement quality
The third goal is to take pictures of the brain to see how it changes with each method This will help researchers understand how the brain adapts after a stroke and could lead to treatments that target the brain directly
Participants will
1 Visit the lab for clinical and research assessments on weeks 1 4 5 and 15
2 Complete 10 days of piano training
3 Undergo magnetic resonance imaging MRI scans twice once in week 1 and once in week 4
Detailed Description:
Forty participants with sub-acute 6 months - 2 years stroke will be recruited in this multi-site trial taking place in Toronto and Montreal Participants will need to be able to perform active finger movements Each site will recruit and randomize participants into one of two training groups Training will consist of
1 One group will focus on improving the quality of their movements while playing music on a digital piano
2 The other group will focus on achieving their movement goals while playing playing music on a digital piano
Participation in this study will involve 14 visits each taking place on a separate day
Piano training consists of 20 hours total spread over 2 hours per day for 5 days across 2 weeks Each participant will receive one-on-one andor group instruction from a Music Therapist with expertise in Neurologic Music Therapy and piano instruction Exercises will include pressing single keys and multiple keys with different fingers holding down certain keys while pressing others and playing melodies and chords with all five fingers involving various coordination patterns rhythms and speeds
Assessments will be conducted at four timepoints Baseline Post-training-1 day 3 Post-training-2 day 7 and Follow-up 3 months Participants will undergo validated clinical assessments to evaluate their ability to move and feel their arm hand and fingers as well as for assessor to understand how the stroke has affected them overall Some of these tests are routinely used by physical therapists and other rehabilitation professionals who work with people living with stroke For other types of tests sensors will be placed on their arm hand and fingers These sensors do not emit anything they will simply record their movements
Kinetic and kinematic measures will assess finger forces grip strength and pinch strength Magnetic resonance imaging MRI scans at Baseline and Post-training-1 will be taken to quantify structure and function of the brain
1 One group will focus on improving the quality of their movements while playing music on a digital piano
2 The other group will focus on achieving their movement goals while playing playing music on a digital piano
Participation in this study will involve 14 visits each taking place on a separate day
Piano training consists of 20 hours total spread over 2 hours per day for 5 days across 2 weeks Each participant will receive one-on-one andor group instruction from a Music Therapist with expertise in Neurologic Music Therapy and piano instruction Exercises will include pressing single keys and multiple keys with different fingers holding down certain keys while pressing others and playing melodies and chords with all five fingers involving various coordination patterns rhythms and speeds
Assessments will be conducted at four timepoints Baseline Post-training-1 day 3 Post-training-2 day 7 and Follow-up 3 months Participants will undergo validated clinical assessments to evaluate their ability to move and feel their arm hand and fingers as well as for assessor to understand how the stroke has affected them overall Some of these tests are routinely used by physical therapists and other rehabilitation professionals who work with people living with stroke For other types of tests sensors will be placed on their arm hand and fingers These sensors do not emit anything they will simply record their movements
Kinetic and kinematic measures will assess finger forces grip strength and pinch strength Magnetic resonance imaging MRI scans at Baseline and Post-training-1 will be taken to quantify structure and function of the brain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None