Back to resultsThe Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
Primary Purpose
Spinal Cord Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
FES+TE
TE
REF-FES+TE
REF-TE
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Chronic spinal cord injury (12 months post injury) Injury in cervical region resulting in tetraparesis Able to sit on a custom made chair without support Does not have any contraindications for functional electrical stimulation
Sites / Locations
- University of TartuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Other
Other
Arm Label
FES+TE
TE
REF-FES+TE
REF-TE
Arm Description
Participants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE)
Participants receiving only therapeutic exercise
Healthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise
Healthy adults that participate only in 1 session and receive only therapeutic exercise
Outcomes
Primary Outcome Measures
Change of median power frequency (MPF) and amplitude (A)
Change of MPF and A is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.
Secondary Outcome Measures
Change of muscle tone
Muscle oscillation frequency (MOF) is measured to assess muscle tone. Change of MOF is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.
Full Information
NCT ID
NCT03517787
First Posted
April 10, 2018
Last Updated
May 4, 2018
Sponsor
Tartu University Hospital
Collaborators
University of Tartu
1. Study Identification
Unique Protocol Identification Number
NCT03517787
Brief Title
The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
Official Title
The Effect of Functional Electrical Stimulation and Therapeutic Exercise on Functional Properties of Skeletal Muscles, Sitting Postural Stability and Quality of Life in Traumatic Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital
Collaborators
University of Tartu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the current study is to evaluate the effect functional electrical stimulation and therapeutic exercise on traumatic spinal cord injured participants'skeletal muscle characteristics, sitting balance, lung function and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FES+TE
Arm Type
Experimental
Arm Description
Participants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE)
Arm Title
TE
Arm Type
Active Comparator
Arm Description
Participants receiving only therapeutic exercise
Arm Title
REF-FES+TE
Arm Type
Other
Arm Description
Healthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise
Arm Title
REF-TE
Arm Type
Other
Arm Description
Healthy adults that participate only in 1 session and receive only therapeutic exercise
Intervention Type
Other
Intervention Name(s)
FES+TE
Intervention Description
Group receive FES+therapeutic exercise during 6 weeks (twice a week). Altogether 8 exercises are conducted, each done 3 sets and 12 repetitions during first three weeks and 4 sets during last three weeks of intervention).
Intervention Type
Other
Intervention Name(s)
TE
Intervention Description
Group perform only therapeutic exercise. Exercises are the same between all 4 groups.
Intervention Type
Other
Intervention Name(s)
REF-FES+TE
Intervention Description
Group perform FES+TE, but only participate in 1 session to collect reference data.
Intervention Type
Other
Intervention Name(s)
REF-TE
Intervention Description
Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.
Primary Outcome Measure Information:
Title
Change of median power frequency (MPF) and amplitude (A)
Description
Change of MPF and A is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.
Time Frame
Change from baseline measure at 6 weeks
Secondary Outcome Measure Information:
Title
Change of muscle tone
Description
Muscle oscillation frequency (MOF) is measured to assess muscle tone. Change of MOF is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.
Time Frame
Change from baseline measure at 6 weeks
Other Pre-specified Outcome Measures:
Title
Change of sitting balance
Description
Sitting balance is measured using Tekscan Conformat pressure mat. Static sitting balance is measured at a custom made stool, hands are placed on participants thighs. For dynamic sitting balance, participants are asked to move their center of pressure to 4 different directions. Distance is measured.
Time Frame
Change from baseline measure at 6 weeks
Title
Quality of life
Description
RAND-36 questionnaire is used to measure health-related quality of life
Time Frame
Change from baseline measure at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Chronic spinal cord injury (12 months post injury) Injury in cervical region resulting in tetraparesis Able to sit on a custom made chair without support Does not have any contraindications for functional electrical stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margot Bergmann, MSc
Phone
+372737 5379
Email
margot.bergmann@ut.ee
First Name & Middle Initial & Last Name or Official Title & Degree
Doris Vahtrik, PhD
Phone
+372737 5379
Email
doris.vahtrik@ut.ee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Vahtrik
Organizational Affiliation
University of Tartu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tartu
City
Tartu
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Vahtrik
Phone
+372737 5379
Email
doris.vahtrik@ut.ee
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
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