跳至主要内容
临床试验/NCT06426862
NCT06426862招募中不适用

To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients.

Riphah International University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Fugl-Meyer Assessment

研究概览

简要总结

This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

详细描述

The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ischemic or hemorrhagic stroke
  • •Medically stable patients with acute to subacute level of stroke recovery (< 6 month).
  • •Patients 40 plus age
  • •Berg balance scale <45 and >20 score
  • •TUG test scoring >20 sec

排除标准

  • •Participants having cognition problem or language barrier
  • •Physical disability (fracture or amputation) other than stroke
  • •Previous surgery 6 weeks
  • •Cardiovascular and pulmonary disease

研究组 & 干预措施

Interventional Group

Experimental

The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly.

干预措施: Otago Exercise Program (Other)

Interventional Group

Experimental

The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly.

干预措施: Control Group (Other)

Control group

Active Comparator

The control group will receive routine treatment of physiotherapy for strokes like strengthening of upper and lower limb muscles (knee flexor, hip adductor and ankle dorsiflexor), stretching (hip abductors and ankle plantar flexor), postural awareness, gait and balance training like static and dynamic. The participants will be assessed through baseline assessment.

干预措施: Control Group (Other)

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: After 6 weeks

Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

Berg Balance Scale

时间窗: After 6 weeks

The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

Time Up & Go Test

时间窗: After 6 weeks

The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

Berg Balance Scale

时间窗: Baseline

The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

Berg Balance Scale

时间窗: After 3 weeks

The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

Time Up & Go Test

时间窗: Baseline

The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

Time Up & Go Test

时间窗: After 3 weeks

The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

Fugl-Meyer Assessment

时间窗: Baseline

Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

Fugl-Meyer Assessment

时间窗: After 3 weeks

Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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