Trial Outcomes & Findings for Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX (NCT NCT02417532)

Results Overview

Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

1 day

Results posted on

2019-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Rex Rehabilitation Patients Tetraplegic and paraplegic patients able to use REX.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rehabilitation Using REX n=56 Participants Exercises using Rex mobility assist device Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	39.8 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment New Zealand	3 participants n=5 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants
Region of Enrollment Australia	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All subjects meeting inclusion criteria. Physically able to properly fit in REX.

Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX

Outcome measures

Outcome measures
Measure	Rehabilitation Using REX n=56 Participants Tetraplegic and paraplegic patients
Ability to Transfer	32 participants

PRIMARY outcome

Timeframe: 1 day

Population: All patients transferring into Rex.

absence of unexpected serious adverse events

Outcome measures

Outcome measures
Measure	Rehabilitation Using REX n=56 Participants Tetraplegic and paraplegic patients
Adverse Events	56 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All patients transferring into Rex

Time it took for participant to transfer into the Rex with or without supervision.

Outcome measures

Outcome measures
Measure	Rehabilitation Using REX n=56 Participants Tetraplegic and paraplegic patients
Transfer Time	352.2 seconds Standard Deviation 75

SECONDARY outcome

Timeframe: 1 Day

Population: Patients who were able to transfer into REX and who could control the joystick. One patient was unable to walk and control Rex so did not complete the questionaire.

overall user satisfaction with the device

Outcome measures

Outcome measures
Measure	Rehabilitation Using REX n=55 Participants Tetraplegic and paraplegic patients
Participant Satisfaction Questionnaire The sound of REX did not bother me % positive	73 percentage of patients
Participant Satisfaction Questionnaire The speed of REX was suitable for me % positive	61 percentage of patients
Participant Satisfaction Questionnaire Easy to Transfer % positive	57 percentage of patients
Participant Satisfaction Questionnaire Confidence % positive	91 percentage of patients
Participant Satisfaction Questionnaire Safety % positive	88 percentage of patients
Participant Satisfaction Questionnaire Stability % positive	89 percentage of patients
Participant Satisfaction Questionnaire Ease of control % positive	84 percentage of patients
Participant Satisfaction Questionnaire Comfort % positive	84 percentage of patients
Participant Satisfaction Questionnaire Wellbeing following use % positive	82 percentage of patients
Participant Satisfaction Questionnaire Benefits to using regularly % positive	91 percentage of patients
Participant Satisfaction Questionnaire The size of REX did not bother me	64 percentage of patients

SECONDARY outcome

Timeframe: 1 Day

Population: Subjects who were able to control the joystick. One patient was unable to control the joystick and was excluded.

The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)

Outcome measures

Outcome measures
Measure	Rehabilitation Using REX n=55 Participants Tetraplegic and paraplegic patients
Timed up and go Test- Ability to Stand From Chair	316.41 seconds Standard Deviation 91.52

Adverse Events

Rehabilitation Using REX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Birch

The Chris Moody Centre

Phone: +44 1604 215440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place