Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT02799966
Status:
TERMINATED
Last Update Posted:
2019-09-26
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Collaborator, MyndTec, withdrew from the study due to lack of resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyndMove
Brief Summary:
Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands and arms. MyndMove is a non-invasive medical device that uses short, low energy electrical pulses with surface electrodes to cause muscle contractions to produce a full range of reaching and grasping movements, which the patient is unable to perform by him/herself.
By using MyndMove therapy to help the individual move their arms and hands as he/she attempts to carry out typical reaching and grasping movements, the individual improves their ability to perform these tasks voluntarily.
The purpose of this study is to study the effectiveness of MyndMove therapy in improving the ability of individuals to move their arms and hands.
By using MyndMove therapy to help the individual move their arms and hands as he/she attempts to carry out typical reaching and grasping movements, the individual improves their ability to perform these tasks voluntarily.
The purpose of this study is to study the effectiveness of MyndMove therapy in improving the ability of individuals to move their arms and hands.
Detailed Description:
There is no control group for this study. Participants from both treatment groups:
* Early treatment group = 10 days to 6 months post tSCI and
* Late treatment group = 6 months plus one day post tSCI
will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).
Each 1 hour session includes therapy for single-arm or bilateral (left and right upper extremities) as clinically indicated for each study participant. Over the course of 20 one hour sessions, participants will progress through the various movement sequences aimed at regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove therapy will be in addition to the conventional upper limb rehabilitation therapy the participant will be prescribed to undertake at their local institution.
From previous experience, the first signs of function recovery may be expected to emerge two to four weeks after the onset of the MyndMove therapy program. As soon as the participant shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle group, s/he will be encouraged to make an effort to voluntarily produce the movement that was previously facilitated by FES. As the participant demonstrates improved strength and range of motion, the FES for that muscle group will be phased out, and moved to another muscle group that is still paralyzed and needs to be "reactivated". The order in which muscle groups will be sequentially "reactivated" will be patient dependent.
Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The number of MyndMove treatments required to reach each milestone will be recorded. In addition, the overall time required to reach each milestone will be recorded.
Total duration of study participation, including a follow-up assessment, will be approximately 4 to 5 months.
* Early treatment group = 10 days to 6 months post tSCI and
* Late treatment group = 6 months plus one day post tSCI
will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).
Each 1 hour session includes therapy for single-arm or bilateral (left and right upper extremities) as clinically indicated for each study participant. Over the course of 20 one hour sessions, participants will progress through the various movement sequences aimed at regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove therapy will be in addition to the conventional upper limb rehabilitation therapy the participant will be prescribed to undertake at their local institution.
From previous experience, the first signs of function recovery may be expected to emerge two to four weeks after the onset of the MyndMove therapy program. As soon as the participant shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle group, s/he will be encouraged to make an effort to voluntarily produce the movement that was previously facilitated by FES. As the participant demonstrates improved strength and range of motion, the FES for that muscle group will be phased out, and moved to another muscle group that is still paralyzed and needs to be "reactivated". The order in which muscle groups will be sequentially "reactivated" will be patient dependent.
Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The number of MyndMove treatments required to reach each milestone will be recorded. In addition, the overall time required to reach each milestone will be recorded.
Total duration of study participation, including a follow-up assessment, will be approximately 4 to 5 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: