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Completed

NCT Number: NCT01958736

Ballistic Strength Training in Stroke: A Pilot Study

This pilot study intends to evaluate whether stroke patients can complete ballistic strength exercises for thirty minutes, three times per week over a six week training period in addition to their existing rehabilitation program.

It will evaluate whether using ballistic training principles, is superior in improving mobility compared with usual care exercises to improve mobility and leg strength in stroke patients.

In this study there will be 15 participants per group, a total of 30 participants. The control group will receive usual care consistent with existing rehabilitation practice and literature. The experimental group will perform task specific strength training in a ballistic fashion.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfred Health - Caulfield Hospital

Melbourne, Victoria, 3162, Australia

About this study

Research Aims:

  • To establish the feasibility of ballistic strength training in stroke and
  • To evaluate the effects of ballistic strength training exercises on mobility outcomes, strength and quality of life when compared with usual care.

Methods:

This wil be a prospective, randomized, controlled, assessor-blinded pilot study. It will be conducted 3 x per week for 6 weeks (i.e. a total of 18 sessions lasting 30 minutes).

Primary outcome measure: Feasibility

  • Recruitment
  • Retention/Attrition
  • Clinical Feasibility
  • Safety

Secondary outcome measures - measured at baseline and completion

  • Ten metre walk test (10MWT) comfortable pace
  • 10MWT maximum safe pace
  • High level mobility assessment tool (HiMAT): Only in participants where 10MWT is <12.5s at baseline
  • Timed up and go test (TUG)
  • Functional Ambulation Category (FAC)
  • Health Related Quality of Life (HRQoL) via AQoL-4D

Description of intervention:

Control Group:

The control group will complete a suite of exercises based upon existing rehabilitation practices that aim to improve mobility after stroke. The supervising physiotherapist will select and progress the exercises, recording the performance of exercises in an exercise log and detailing incidence of adverse events. Exercise selection will include: gait retraining, cardiovascular fitness, lower limb strengthening, static and dynamic balance

Experimental group:

The experimental group will complete jump squats on the leg sled, single leg toe push offs (or bilateral where unable to complete single), alternating legs (i.e. bounding), mini tramp jumping, progressing to jogging, quick hip flexion and bounding on land.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient at Caulfield Hospital Neurological Rehabilitation Unit at the time of recruitment
  • Diagnosis of first stroke
  • Presence of lower limb weakness determined by >10% difference in knee extensor strength between sides
  • Functional Ambulation Category (FAC) > 3
  • Can walk a minimal distance of 14 metres (to allow measurement on a 10metre walk test (10MWT)

Participants who meet all the inclusion criteria except for their FAC score will have their FAC score re-measured on a weekly basis until they reach a score of greater than or equal to 3, at which point they become eligible and will be approached for recruitment.

Exclusion criteria

  • Unable to provide informed consent (determined by consultation with rehabilitation consultant and the team neuropsychologist)
  • Other diagnosed central nervous system disorder affecting mobility
  • Active oncological diagnosis
  • Unstable medication condition such as unstable diabetes or unstable cardiac condition that would prevent participation in cardiovascular activity
  • Recent orthopaedic trauma and/or osteoarthritis that would limit participation in physical exercise
  • Not willing to continue to attend the program if they discharge home before the end of the six week program

Treatment and study plan

Ballistic Strength Training

Other

The experimental group will complete jump squats on the leg sled, single leg toe push offs (or bilateral where unable to complete single), alternating legs (i.e. bounding), mini tramp jumping, progressing to jogging, quick hip flexion and bounding on land.

Usual care Physiotherapy

Other

This group will complete a suite of exercises based upon existing rehabilitation practices that aim to improve mobility after stroke. The supervising physiotherapist will select and progress the exercises, recording the performance of exercises in an exercise log and detailing incidence of adverse events. Exercise selection will include: gait retraining, cardiovascular fitness, lower limb strengthening, static and dynamic balance.

Primary outcomes

  1. Feasibility

    Time frame: 6 weeks

    Recruitment:

    • Number of stroke admissions to Caulfield Hospital
    • Number of stroke admissions that meet the inclusion/exclusion criteria
    • Number of those eligible who consent to participate

    Retention/Attrition:

    • Drop out rates over the six week period and reasons for drop outs
    • Number of sessions attended out of 18 over the six week period

    Clinical feasibility

    • Capacity of participants to perform the required exercises
    • Level of assistance required by therapist to perform the exercises - i.e. independent, supervision, assisted
    • Barriers to completing the required exercises during a session, i.e. incidence of delayed onset muscle soreness, fatigue
    • To be recorded for every session

    Safety

    • Incidence of adverse events
    • Types of adverse events
    • To be recorded for every session

Secondary outcomes

  1. 10 metre walk test comfortable pace

    Time frame: Baseline and 6 weeks

    Participants will be measured at comfortable gait speed. The middle 10metres of a 14 metre track will be recorded. The participant will be asked to walk at their own comfortable speed. There will be a cone at the start and finish of the 14metre track to guide participants and the middle 10 metres will be recorded.

  2. 10 metre walk test, maximum safe pace

    Time frame: Baseline and 6 weeks

    Same set-up as 10MWT comfortable pace, however the participant will be asked to walk as fast as they safely can without breaking into a run.

  3. High level mobility assessment tool (HiMAT)

    Time frame: Baseline and 6 weeks

    The HiMAT is a 13 item assessment tool designed to assess high level walking tasks, the ability to negotiate stairs and the ability to run, hop, skip and jump. The HiMAT will be used to evaluate performance for higher level participants in the study where their 10MWT result may have a ceiling effect (where participants complete 10MWT in under 12.5seconds).

  4. Timed up and go test (TUG)

    Time frame: Baseline and 6 weeks

    The TUG is highly reliable in stroke populations and correlates with walking performance and incidence of falls. Participants will be measured on the TUG from a 45cm chair. The will be asked to complete the test at their own comfortable speed.

  5. Functional Ambulation Category (FAC)

    Time frame: Baseline and 6 weeks

    The FAC is a simple tool which uses an ordinal scale of 1 to 6 to measure the level of assistance a person requires to walk, and the different types of terrain they can manage such as indoors vs. outdoors, slopes and inclines.

  6. Assessment of quality of life 4D

    Time frame: Baseline and 6 weeks

    Health related quality of Life will be measured using the Assessment of quality of life 4D. This has been shown to be a valid and sensitive measure in stroke, and has been used to determine the effects of mobility on HRQoL in neurological populations.

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Collaborators

  • Australian Catholic University

Registry information

Official study title

Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2013
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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