Effects of overnight electrical stimulation on local oxygenation and muscle thickness in people with spinal cord injury

Effects of overnight electrical stimulation on local oxygenation and muscle thickness in people with spinal cord injury - Overnight electrical stimulation in people with spinal cord injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37894

Enrollment

Registered

2012-04-12

Start date

2012-05-23

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paraplegia Spinal cord injury

Interventions

Subjects will be stimulated every night throughout the experiments (2 weeks or 4 months). The subjects will take their ES shorts and neuromuscular electrical stimulators home and subjects are asked

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are cervical or thoracic lesions, ASIA A/B. Subjects have to be at least 1 year post injury

Exclusion criteria

Exclusion criteria: Subjects with (cardio)vascular diseases, diabetes, hypercholesterol or high blood pressure will be excluded. Furthermore subjects with an intolerance to electrical stimulation, presence of pressure ulcers on ischial tuberosity area or sacrum, presence of a pacemaker or metal implants near stimulation area are excluded.

Design outcomes

Primary

Measure	Time frame
Primary study parameters for both experiments are listed below. Experiment 1: Tissue saturation in gluteal area in different conditions and effect of two weeks of overnight stimulation using Near Infrared Spectroscopy (NIRS) Oxygen uptake and blood flow in Vastus lateralis and effect of two weeks of overnight stimulation using NIRS Usability of overnight electrical stimulation. Determined by questionnaires( PSQI, SQ-VAS, Usability questionnaire) Experiment 2: Thickness of gluteus maximus muscle and effect of four months of overnight stimulation, determined by CT scan Usability of overnight electrical stimulation. Determined by questionnaires( PSQI, SQ-VAS, Usability questionnaire)	—

Measure

Time frame

Primary study parameters for both experiments are listed below. Experiment 1: Tissue saturation in gluteal area in different conditions and effect of two weeks of overnight stimulation using Near Infrared Spectroscopy (NIRS) Oxygen uptake and blood flow in Vastus lateralis and effect of two weeks of overnight stimulation using NIRS Usability of overnight electrical stimulation. Determined by questionnaires( PSQI, SQ-VAS, Usability questionnaire) Experiment 2: Thickness of gluteus maximus muscle and effect of four months of overnight stimulation, determined by CT scan Usability of overnight electrical stimulation. Determined by questionnaires( PSQI, SQ-VAS, Usability questionnaire)

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Secondary

Measure	Time frame
Experiment 1 Energy expenditure in rest and during electrical stimulation and effect of two weeks of overnight stimulation using COSMED Interface pressure while sitting compared to baseline using mFlex Muscle fatigue, compared to baseline using load cell. Experiment 2 Tissue saturation in gluteal area in different conditions and effect of four months of overnight stimulation using Near Infrared Spectroscopy (NIRS) Oxygen uptake and blood flow in Vastus lateralis and effect of four months of overnight stimulation using NIRS Energy expenditure in rest and during electrical stimulation and effect of four months of overnight stimulation using COSMED Interface pressure while sitting compared to baseline using mFlex	—

Measure

Time frame

Experiment 1 Energy expenditure in rest and during electrical stimulation and effect of two weeks of overnight stimulation using COSMED Interface pressure while sitting compared to baseline using mFlex Muscle fatigue, compared to baseline using load cell. Experiment 2 Tissue saturation in gluteal area in different conditions and effect of four months of overnight stimulation using Near Infrared Spectroscopy (NIRS) Oxygen uptake and blood flow in Vastus lateralis and effect of four months of overnight stimulation using NIRS Energy expenditure in rest and during electrical stimulation and effect of four months of overnight stimulation using COSMED Interface pressure while sitting compared to baseline using mFlex

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)