Clinical trial NCT01958736: Ballistic Strength Training in Stroke: A Pilot Study
Official title: Ballistic Strength Training in Stroke: A Phase II Randomized, Controlled, Assessor Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Australian Catholic University
First posted: 2013-10-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: 10 metre walk test comfortable pace
timeFrame: Baseline and 6 weeks
measure: 10 metre walk test, maximum safe pace
timeFrame: Baseline and 6 weeks
measure: High level mobility assessment tool (HiMAT)
timeFrame: Baseline and 6 weeks
measure: Timed up and go test (TUG)
timeFrame: Baseline and 6 weeks
measure: Functional Ambulation Category (FAC)
timeFrame: Baseline and 6 weeks
measure: Assessment of quality of life 4D
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Health - Caulfield Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Genevieve C Hendrey, B Phys (Hons)
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred Health and La Trobe University
name: Anne E Holland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Epworth Healthcare, Melbourne University, La Trobe University
name: Gavin Williams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Australian Catholic University
name: Ross Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hendrey G, Clark RA, Holland AE, Mentiplay BF, Davis C, Windfeld-Lund C, Raymond MJ, Williams G. Feasibility of Ballistic Strength Training in Subacute Stroke: A Randomized, Controlled, Assessor-Blinded Pilot Study. Arch Phys Med Rehabil. 2018 Dec;99(12):2430-2446. doi: 10.1016/j.apmr.2018.04.032. Epub 2018 May 30.