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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837834
Other study ID # 201682-4100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date September 5, 2019

Study information

Verified date September 2019
Source Universiti Teknologi Mara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The training consists of 6 weeks of functional electrical stimulation leg cycling exercise (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the stimulation intensity based on the participant's tolerance level.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 5, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year prior to participation.

- Age between 18-75 years old.

- Both male and female.

- Have at least 90ยบ bilateral knee flexion.

- Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual muscle testing).

- Able to perform cycling activity.

- Normal upper limb function.

- Able to follow command.

Exclusion Criteria:

- Had a recent history of trauma to the lower limb.

- Severely infected skin pressure sore on weight-bearing skin areas.

- Illness caused by acute urinary tract infection.

- Uncontrolled spasticity or pain.

- History of cardiovascular/cardiorespiratory problem.

- Orthostatic hypotension.

- Unhealed decubiti at electrode placement area.

- Recurrent autonomic dysreflexia.

- Active heterotopic ossification.

- Other peripheral or central neurologic injury.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Functional Electrical Stimulation Leg Cycling Exercise
FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.

Locations

Country Name City State
Malaysia University Malaya Medical Center Kuala Lumpur

Sponsors (2)

Lead Sponsor Collaborator
Universiti Teknologi Mara University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of peak torque of Quadriceps and Hamstring Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine. Changes of peak torque at 6 week
Secondary Changes of peak VO2 Peak VO2 will be measured using Cosmed Quark CPET system apparatus Changes of peak VO2 at 6 week