Trial Outcomes & Findings for Biomechanics of Wheelchair Transfers (NCT NCT00645567)

NCT ID: NCT00645567

Last Updated: 2017-04-07

Results Overview

measurement of applied shoulder force during wheelchair transfers

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: None reported - verifiable data is not available for any of the participants
• Results posted on: 2017-04-07

Participant Flow

Although 10 individuals signed ICs, 4 actually actively participated in the study as one was dropped due to an unrelated injury.

Participant milestones

Measure	Wheelchair Transfer Interventions 5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Wheelchair Transfer Interventions 5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
Overall Study Adverse Event	1

Baseline Characteristics

Biomechanics of Wheelchair Transfers

Baseline characteristics by cohort

Measure	Wheelchair Transfer Interventions n=5 Participants Persons with SCI who evaluated wheelchair transfer interventions
Age, Continuous	47.8 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: None reported - verifiable data is not available for any of the participants

Population: As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants.

measurement of applied shoulder force during wheelchair transfers

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=5 participants at risk persons with SCI
Musculoskeletal and connective tissue disorders Hand injury	20.0% 1/5 • Number of events 1

Additional Information

John Lloyd

James A Haley VA, Tampa

Phone: 813-624-8986

Email: john.lloyd2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place