A home based program for improving balance in acquired brain injury patients

ISRCTN ISRCTN37857836
DOI https://doi.org/10.1186/ISRCTN37857836
Secondary identifying numbers N/A
Submission date
12/12/2011
Registration date
16/01/2012
Last edited
18/01/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Acquired brain injury (ABI) is damage to the brain caused by trauma or other causes (for example, lack of oxygen or haemorrhage). Patients may have a combinations of physical, communicative, cognitive, behavioural, psychosocial and environmental problems. Rehabilitation is a problem-solving educational process aimed at reducing the disability experienced as a result of disease or injury. The rehabilitation will be personal, social, and physical. Different individuals will need different programs of rehabilitation and they will need different programs of rehabilitation at different stages in their recovery.

Problems of balance are among the most frequent problems treated by physical therapists in patients with ABI. Several studies conclude that the use of programs in which patients have a cognitive or motor task (store a sequence of numbers or manipulate objects) while keeping their balance are more effective. Scientific research recommends rehabilitation for long periods and in everyday situations. The aim of this study is to evaluate the effectiveness of a home-based program, without direct guidance of physiotherapist, in addition to traditional physical therapy.

Who can participate?
Participants were of working age (between 18 and 55 years old) and suffering from ABI. They included patients who were attending an outpatient clinic, one year after suffering an injury.

What does the study involve?
All participants received 50-minute individualized physiotherapy sessions for balance disorders, 3 times a week for 7 weeks.
In addition, the study group carried out a series of individual exercises at home for approximately 30 minutes, 6 times a week for 7 weeks, independently or with the help of a caregiver:
1. Body stability with sensory deprivation (standing with eyes closed, standing on foam)
2. With different supports (tandem standing, on one foot)
3. Body transport (transferring from one chair to another, going from sitting to standing)
4. Balance tasks while simultaneously performing a second motor task (pulling up and retrieving a ball, throwing and catching a ball while holding a tray with glasses)
5. Cognitive tasks, (naming objects and remembering numbers)
There was a booklet containing exercises and individualized information for each patient. Every booklet was revised weekly during the physiotherapy session.

What are the possible benefits and risks of participating?
There were no known risks to participants.

Where is the study run from?
We conducted the study one rehabilitation centre: Presidio Sanitario Ausiliatrice – Fondazione Don Gnocchi Onlus, Turin, Italy.

When is study starting and how long is it expected to run for?
Patients were enrolled in the study in May 2011. The training started in October 2011 and ended in December 2011.

Who is funding the study?
Presidium Health "Help" Rehabilitation Centre [Presidio Sanitario Ausiliatrice – Fondazione Don Gnocchi Onlus], Italy and the University of Piemonte Orientale, Italy.

Who is the main contact?
Dr Eliana Peirone
epeirone@libero.it

Contact information

Dr Eliana Peirone
Scientific

Via S. Bermado, 9
Fossano
12045
Italy

Study information

Study designInterventional randomised single blind single centre controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA dual task home based program for improving balance in acquired brain injury patients: single blind, randomised controlled trial of efficacy
Study objectivesMulti task programs are more effective in balance improvement than single task programs.

Home based programs are effective in improving mobility in people after stroke rehabilitation. Intensive rehabilitation programs improve the speed of functional recovery in acquired brain injury (ABI) patients.

The effect of the current financial and economic recession in Europe and in Italy on national health systems are not compatible with the times and needs of people with disabilities. A dual task home based program without direct therapist supervision, extra traditional physical therapy in day hospital, is effective in balance improvement and postural control in patients with severe acquired brain injury, more than one year after the injury, compared to conventional therapy in day hospital.
Ethics approval(s)University of Piemonte Orientale, Italy, 20 April 2011
Health condition(s) or problem(s) studiedAcquired brain injury
InterventionParticipants were randomly assigned to one of two groups: a study group and a control group.

Participants completed a battery of balance, attention and multi task assessments. They created a functional target for the end of the training. Participants received 50 minute individualized training sessions of traditional physiotherapy in rehabilitation centre, three times a week for 7 weeks, for balance disorders in accordance with the rules of good practice.

In addition, the study group performed a battery of individual exercises at home for approximately 30 minutes for 6 days a week for 7 weeks. The exercises were exercices of balance in dual task (cognitive and motor) with sensory deprivation, standing with feet together, monopodal, belt. Balance training session followed Gentile's Taxonomy of Movements task.

For each patient a booklet was prepared containing exercises and individualised information about the environmental changes. Every booklet was been revised weekly during a physiotherapy session in the rehabilitation centre.
Intervention typeOther
Primary outcome measureOne Leg Stand Test - right and left in single and multi task conditions (where normal= stable for 20 seconds; unable = stable for <2 sec )
This is a simple, predictive and inexpensive marker, which is helpful in screening for low functional level in clinical practice
Secondary outcome measures1. Balance Evaluation Systems Test (BES Test) (normal=108) to identify the disordered systems undelying balance control
2. Activities-specific Balance Confidence (ABC) scale, to determine self-reported confidence when performing 16 different daily activities. (where 0% no confidence; 100% full confidence)
3. Goal Attainment Scaling (GAS), an individualized criterion referenced measure of change suitable for measuring the impact of an intervention (where -2=much worse; +2 = much better)

These were measured at baseline and at the end of the seven weeks of training, precisely during the week following the conclusion of training.
Overall study start date03/10/2011
Completion date10/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants45 potential candidates to study of which 16 were included, 8 males and 8 females
Key inclusion criteria1. Aged between 18 and 55 years
2. Male and female participants
3. 12 - 18 months with ABI
4. Balance deficits with the "One Leg Stance" test - patients scored less than 10 seconds on this test
Key exclusion criteria1. Previous diagnosis of neurodegenerative diseases and psychiatric disorders
2. Presence of serious heart disease
3. Presence of serious cognitive-behavioral disorders
4. Changes to the treatment of muscle relaxant and antispasmodic drugs during the period of enrollment
Date of first enrolment03/10/2011
Date of final enrolment10/12/2011

Locations

Countries of recruitment

  • Italy

Study participating centre

Via S. Bermado, 9
Fossano
12045
Italy

Sponsor information

Don Gnocchi Foundation Health Centre (Italy)
Hospital/treatment centre

Presidio Sanitario "Ausiliatrice" - Onlus Don Gnocchi Foundation
Street 42 Peyron
Torino
12045
Italy

ROR logo "ROR" https://ror.org/02e3ssq97

Funders

Funder type

University/education

Presidium Health "Help" Rehabilitation Centre [Presidio Sanitario Ausiliatrice – Fondazione Don Gnocchi Onlus] (Italy)

No information available

University of Piemonte Orientale (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan