Spinal Cord InjuriesNCT03517787
The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life
A study testing FES+TE, TE and REF-FES+TE in people with Spinal Cord Injuries, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- FES+TE, TE and REF-FES+TE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEstonia
- Study dates
- 3 Mar 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES+TE, TE, REF-FES+TE, REF-TE
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES+TEOther
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).
TEOther
Group perform only therapeutic exercise. Exercises are the same between all 4 groups.
REF-FES+TEOther
Group perform FES+TE, but only participate in 1 session to collect reference data.
REF-TEOther
Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.
| Study group | Role | What they receive |
|---|---|---|
| FES+TE | Experimental | Participants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE) Receives: Other: FES+TE |
| TE | Active comparator | Participants receiving only therapeutic exercise Receives: Other: TE |
| REF-FES+TE | Other | Healthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise Receives: Other: REF-FES+TE |
| REF-TE | Other | Healthy adults that participate only in 1 session and receive only therapeutic exercise Receives: Other: REF-TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline measure at 6 weeks
Secondary outcomes (1)
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.
Measured: Change from baseline measure at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start3 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Principal investigator, Margot Bergmann, Tartu University Hospital
- Investigators
- Doris Vahtrik, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517787
- Sponsor's protocol ID
- Spinaal
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2018
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03517787
- Acronym / sponsor ID
- Spinaal
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FES+TE | Experimental | Other: FES+TEParticipants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE) |
| TE | Active comparator | Other: TEParticipants receiving only therapeutic exercise |
| REF-FES+TE | Other | Other: REF-FES+TEHealthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise |
| REF-TE | Other | Other: REF-TEHealthy adults that participate only in 1 session and receive only therapeutic exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES+TEGroup 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). | Other | FES+TE |
| TEGroup perform only therapeutic exercise. Exercises are the same between all 4 groups. | Other | TE |
| REF-FES+TEGroup perform FES+TE, but only participate in 1 session to collect reference data. | Other | REF-FES+TE |
| REF-TEGroup perform only therapeutic exercise, but only participate in 1 session to collect reference data. | Other | REF-TE |
Primary outcome
Change of median power frequency (MPF) and amplitude (A)
Time frame: Change from baseline measure at 6 weeks
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.
1 secondary outcome
Change of muscle tone
Time frame: Change from baseline measure at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Vahtrik principal investigator
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES+TE, TE and REF-FES+TE in people with Spinal Cord Injuries, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of median power frequency (MPF) and amplitude (A) (time frame: Change from baseline measure at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.