Does Improved Ability to Achieve Single Leg Stance Lead to a More Efficient Gait Pattern in Adults With Acquired Brain Injury?

NCT04062149 | Completed

• 1 other identifier: B00678
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if a person can stand better on their weaker leg does this improve their walking ability following treatment specifically aimed at standing on leg. This will be compared to people who receive normal physiotherapy treatment not treatment specifically focusing on their ability to stand on their weaker leg. The study is being carried out as part of the researcher's Masters Degree. Participants will be allocated to either the control group (normal physiotherapy treatment) or the experimental group (normal physiotherapy plus physiotherapy working specifically on standing on the weaker leg). There is currently some evidence to show that working specifically on standing on one leg can improve a person's walking but this evidence is limited. Consequently, further research is warranted to identify any links between this treatment approach and walking ability.

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• Number of participants with improved gait speed as measured by an increase in metres per second in the 10m walk test (10MWT)

  The 10m walk test (10MWT) is a measure of gait speed. Time to walk 10m is converted to metres/second. This will be completed pre and post intervention and the difference compared. An increase in speed (metres per second) demonstrates a positive outcome. A change of greater than 0.14m/s indicates a clinical important difference.

  6 weeks

Secondary Outcomes (1)

• Number of participants who improve their ability to achieve single leg stance (SLS) with a change in Goal Attainment Scale (GAS) T-score of greater than 10

  6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will be the group where the participants receive only their normal physiotherapy treatment.

Other: Usual physiotherapy

Experimental Group

EXPERIMENTAL

The experimental group will be the group where participants receive physiotherapy aimed at improving their ability to stand on their weaker leg alongside their normal physiotherapy treatment.

Other: single leg stance treatment

Interventions

single leg stance treatment OTHER

SLS treatment following the neurodevelopmental treatment (NDT). SLS is the ability of one limb to support the body's weight in a standing position. In gait it is the foot being in contact with the ground whilst the body passes over it and this stance phase of gait accounts for 60% of the gait cycle. The treatment approach of NDT has been chosen as this is the most common physiotherapy treatment option in the UK and is the most common option in the studies above. NDT is a problem-solving approach to the assessment and treatment of individuals with disturbances of function, movement and postural control due to a lesion of the central nervous system and provides an outline of the treatment required to achieve SLS which will form the basis of the intervention of this study.

Experimental Group

Usual physiotherapy OTHER

Individualised physiotherapy treatment approach, as per standard protocol, but it will not work specifically on SLS. Will be based on the neuro-developmental technique.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an ABI as diagnosed by a doctor following a brain scan
• Adults aged eighteen years or over
• Patients can be male or female
• Mobile \>10m with or without assistance/walking aid
• Willing and able to provide written informed consent and scores \>5 on orientation on FIM+FAM (FIM+FAM is an outcome measure used in all neuro-rehabilitation units in England, consequently, these data are already captured by the unit)
• Medically stable - able to fully take part in regular therapy - as determined by the unit's medical team

You may not qualify if:

• Diagnosed with a progressive neurological condition by a doctor
• Below eighteen years of age
• Mobile \<10m or not mobile
• Unable or unwilling to give informed consent or scores \<5 on orientation on FIM+FAM Medically unwell

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Salford: collaborator

Study Sites (1)

Trafford General Hospital

Manchester, M41 5SL, United Kingdom

Location

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MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if thy have been allocated to the control or experimental group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Exploratory pre-test - post-test experimental design

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: December 24, 2019
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)