Ballistic Strength Training in Stroke: A Pilot Study

NCT01958736 | Completed

• 1 other identifier: 369/13
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 10 metre walk test comfortable pace

  Baseline and 6 weeks

• 10 metre walk test, maximum safe pace

  Baseline and 6 weeks

• High level mobility assessment tool (HiMAT)

  Baseline and 6 weeks

• Timed up and go test (TUG)

  Baseline and 6 weeks

• Functional Ambulation Category (FAC)

  Baseline and 6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Ballistic Strength Training

Other: Ballistic Strength Training

Control

ACTIVE COMPARATOR

Usual care Physiotherapy

Other: Usual Care Physiotherapy

Interventions

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.

Experimental

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.

Control

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead
• Australian Catholic University: collaborator

Study Sites (1)

Alfred Health - Caulfield Hospital

Melbourne, Victoria, 3162, Australia

Location

Related Publications (1)

• 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.

  PMID: 29859180 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Genevieve C Hendrey, B Phys (Hons)

  The Alfred

  PRINCIPAL INVESTIGATOR

• Anne E Holland, PhD

  Alfred Health and La Trobe University

  PRINCIPAL INVESTIGATOR

• Gavin Williams, PhD

  Epworth Healthcare, Melbourne University, La Trobe University

  PRINCIPAL INVESTIGATOR

• Ross Clark, PhD

  Australian Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms. Rowan Frew

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: February 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

AU (1)