Ballistic Strength Training in Stroke: A Pilot Study

NCT ID: NCT01958736

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

Ballistic Strength Training

Group Type: EXPERIMENTAL

Ballistic Strength Training

Intervention Type: 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.

Control

Usual care Physiotherapy

Group Type: ACTIVE_COMPARATOR

Usual Care Physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian Catholic University

OTHER

Sponsor Role: collaborator

Bayside Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ms. Rowan Frew

Ms. Rowan Frew

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Genevieve C Hendrey, B Phys (Hons)

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Anne E Holland, PhD

Role: PRINCIPAL_INVESTIGATOR

Alfred Health and La Trobe University

Gavin Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Epworth Healthcare, Melbourne University, La Trobe University

Ross Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

Australian Catholic University

Locations

Alfred Health - Caulfield Hospital

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 29859180 (View on PubMed)

Other Identifiers

369/13

Identifier Type: -

Identifier Source: org_study_id