Soft extra muscle glove study for spinal cord injury

Clinical trial of the Soft Extra Muscle Glove to assess orthotic and long-term functional gain following chronic incomplete tetraplegia: A longitudinal mixed methods study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98677526

Enrollment

Registered

2017-06-01

Start date

2016-11-01

Completion date

Unknown

Last updated

2020-03-30

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

Conditions

Specialty: Neurological disorders, Primary sub-specialty: Other

Interventions

Participants will be provided with a SEM Glove unit to use for activities of daily living for a total of 12 weeks. Using questionnaires, neurophysiological and functional measures, th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years 2. Incomplete tetraplegia (spinal level C2 – C8) , AIS grade C or D 3. At least 12 months post SCI (chronic) 4. Reduced muscle power resulting in reduced grip/pinch strength

Exclusion criteria

Exclusion criteria: 1. Known neurological condition, comorbidity (eg. brain injury). 2. A person unable to understand verbal or written information in English.

Design outcomes

Primary

Measure	Time frame
Hand function is measured using dynamometry and Toronto Rehabilitation Institute hand function test at baseline, 6 week,12 weeks and 18 weeks.	—

Secondary

Measure	Time frame
1. Pain is measured using the Visual analogue scale (VAS) at baseline, 6 week,12 weeks and 18 weeks. 2. Sensation is measured using The Rivermead Assessment of Somatosensory Performance (RASP) at baseline and 12 weeks 3. Spasticity is measured using Modified Ashworth Scale (MAS) test:- at baseline, 6 week,12 weeks and 18 weeks. 4. Spinal cord injury level is measured using the American Spinal Injury Association Impairment Scale (AIS) at baseline and 12 weeks 5. Performance and satisfaction rating of selected activities is measured using Canadian Occupational Performance Measure (COPM) at baseline and 12 weeks 6. The level of independence is assessed using the self-care sub-scale of spinal cord independence measure (SCIM) at baseline and 12 weeks 7. Quality of life is measured using the short form 36 at baseline and 12 weeks 8. The usability of the glove is assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) at 12 weeks	—

Measure

Time frame

1. Pain is measured using the Visual analogue scale (VAS) at baseline, 6 week,12 weeks and 18 weeks. 2. Sensation is measured using The Rivermead Assessment of Somatosensory Performance (RASP) at baseline and 12 weeks 3. Spasticity is measured using Modified Ashworth Scale (MAS) test:- at baseline, 6 week,12 weeks and 18 weeks. 4. Spinal cord injury level is measured using the American Spinal Injury Association Impairment Scale (AIS) at baseline and 12 weeks 5. Performance and satisfaction rating of selected activities is measured using Canadian Occupational Performance Measure (COPM) at baseline and 12 weeks 6. The level of independence is assessed using the self-care sub-scale of spinal cord independence measure (SCIM) at baseline and 12 weeks 7. Quality of life is measured using the short form 36 at baseline and 12 weeks 8. The usability of the glove is assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) at 12 weeks

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026