Ballistic Strength Training in Stroke: A Pilot Study

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958736
• Other study ID #: 369/13
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 17, 2016
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Research Aims:

1. To establish the feasibility of ballistic strength training in stroke and

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Ballistic Strength Training
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
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.

Locations

Country	Name	City	State
Australia	Alfred Health - Caulfield Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Australian Catholic University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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	6 weeks	Yes
Secondary	10 metre walk test comfortable pace	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.	Baseline and 6 weeks	No
Secondary	10 metre walk test, maximum safe pace	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.	Baseline and 6 weeks	No
Secondary	High level mobility assessment tool (HiMAT)	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).	Baseline and 6 weeks	No
Secondary	Timed up and go test (TUG)	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.	Baseline and 6 weeks	No
Secondary	Functional Ambulation Category (FAC)	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.	Baseline and 6 weeks	No
Secondary	Assessment of quality of life 4D	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.	Baseline and 6 weeks	No