Trial Outcomes & Findings for Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task? (NCT NCT02666560)

NCT ID: NCT02666560

Last Updated: 2016-08-31

Results Overview

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

Results posted on

2016-08-31

Participant Flow

Recruitment occurred at an NHS FoundationTrust between March to April 2015. Twenty-six children with Cerebral Palsy who were currently on the paediatric physiotherapy caseload met the inclusion criteria, so were invited to participate. A total of nineteen children chose to participate in this research project.

Participant milestones

Participant milestones
Measure
Cueing Self Paced Then Cueing 20% Above Self Paced Cadence
Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence. Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence.
Cueing at 20% Above Self Paced Cadence Then Self Based Cadence
Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence. Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence.
Condition 1 (1 Day)
STARTED
8
11
Condition 1 (1 Day)
COMPLETED
8
11
Condition 1 (1 Day)
NOT COMPLETED
0
0
Condition 2 (1 Day)
STARTED
8
11
Condition 2 (1 Day)
COMPLETED
8
11
Condition 2 (1 Day)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Increasing Auditory Cueing Affect Gait Parameters in Children With Cerebral Palsy During a Functional Task?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=19 Participants
Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence. Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence. This was a crossover design where participants completed both arms in the trial.
Age, Categorical
<=18 years
19 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
104.3 months
STANDARD_DEVIATION 25.5 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Step Length as Measured by the Gaitrite Walk-way System.
51.32 cm
Standard Deviation 6.42
53.36 cm
Standard Deviation 8.07

SECONDARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Velocity as Measured by the Gaitrite Walk-way System.
98.62 cm/s
Standard Deviation 16.29
101.77 cm/s
Standard Deviation 21.08

SECONDARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Step Time as Measured by the Gaitrite Walk-way System.
0.53 seconds
Standard Deviation 0.09
0.52 seconds
Standard Deviation 0.08

SECONDARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Cadence as Measured by the Gaitrite Walk-way System.
115.27 steps per minute
Standard Deviation 15.75
117.09 steps per minute
Standard Deviation 15.97

SECONDARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Time Spent in Double Support as Measured by the Gaitrite Walk-way System.
0.30 percentage of time
Standard Deviation 0.91
0.29 percentage of time
Standard Deviation 0.09

SECONDARY outcome

Timeframe: Data was collected at a single time point for each condition. Conditions occurred within a two week time period.

The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).

Outcome measures

Outcome measures
Measure
ACSC
n=19 Participants
Auditory cueing at self paced cadence
AC20
n=19 Participants
Auditory cueing set at 20% above self paced cadence
Time Spent in Single Support as Measured by the Gaitrite Walk-way System.
0.38 percentage of time
Standard Deviation 0.05
0.39 percentage of time
Standard Deviation 0.05

Adverse Events

Auditory Cueing at Self Paced Cadence

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cueing at 20% Above Self Paced Cadence

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

Joanne Lindop

University College London

Phone: 07909116145

Results disclosure agreements

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