Trial Outcomes & Findings for Investigating the Clinical and Cost Effectiveness of Lycra Splinting (NCT NCT02345512)

NCT ID: NCT02345512

Last Updated: 2020-04-24

Results Overview

Self-report fall calendar completed daily during the 6-week intervention period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-04-24

Participant Flow

Participants were recruited via the National Health service physiotherapists in 2 Health Boards.

Participant milestones

Participant milestones
Measure	Lycra Splint Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lycra Splint Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Investigating the Clinical and Cost Effectiveness of Lycra Splinting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lycra Splint n=11 Participants Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United Kingdom	11 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Adults with Intellectual Disabilities with gait issues who experienced a fall within the last 12 months

Self-report fall calendar completed daily during the 6-week intervention period

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention All participants post intervention
Falls	3 Falls Interval 0.0 to 12.0	—

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with gait or balance issues who have experienced a fall in previous 12 months

The standard deviation of the Center of Pressure during quiet standing. The standard deviation of this measure is used as the outcome as it is the dispersion of the location of the centre of pressure that is of interest.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Center of Pressure Standard Deviation	10.6 mm Interval 5.3 to 24.0	9.8 mm Interval 4.6 to 20.7

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with balance or gait issues who fall

The walking speed along a standardised walking mat.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Walking Speed	0.593 m/s Interval 0.325 to 0.836	0.594 m/s Interval 0.318 to 0.842

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with gait or balance issues who have fallen in previous 12 months

Distance from initial foot contact on one side to initial foot contact on contralateral side.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Step Length	0.402 m Interval 0.243 to 0.588	0.398 m Interval 0.23 to 0.533

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with Intellectual Disabilities with Gait or Balance Issues who Fall

Width between heel strikes perpendicular to direction of travel

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Base of Support	0.187 m Interval 0.034 to 0.31	0.196 m Interval 0.066 to 0.322

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months

The symmetry was calculated as the ratio between the longest and shortest of the left and right step lengths. This provides an indication of the level of symmetry between sides. A score of 1 indicates complete symmetry with values less than one becoming progressively less symmetrical.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Step Symmetry	0.86 ratio Interval 0.59 to 1.0	0.86 ratio Interval 0.62 to 0.98

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months

Percentage of the gait cycle where both feet are on the ground together.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Double Support Time as a Percentage of the Gait Cycle	56.30 percentage of the gait cycle Interval 44.21 to 68.74	55.80 percentage of the gait cycle Interval 42.61 to 66.65

PRIMARY outcome

Timeframe: 6 week intervention period

Population: Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months

The time taken to complete the Timed Up and Go Test.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention n=9 Participants All participants post intervention
Timed Up and Go Test Time	20.68 s Interval 9.67 to 40.53	19.71 s Interval 10.48 to 42.07

SECONDARY outcome

Timeframe: 6 week intervention period

Population: adults with intellectual disabilities who had experienced a fall in the last 12 months

Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants All participants (no subgroups or arm)	Post Intervention All participants post intervention
Number of Participants That Were Compliant With Lycra Splinting Garment Wear	9 participants	—

Adverse Events

Lycra Splint

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lycra Splint n=11 participants at risk Wearing of Lycra splinting garment Lycra Splinting Garment: Wearing of lycra splinting garment for 6 weeks
Skin and subcutaneous tissue disorders Bruising	9.1% 1/11 • Number of events 1 • Adverse event data was collected over the study data collection period which was 6 months.

Additional Information

Ms Jennifer Crockett

National Health Service Greater Glasgow & Clyde

Phone: 0141 276 4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place